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Want a life-changing psychedelic trip but don’t know where to start?: issue 26

Here’s what’s in store for you in today’s issue:

🍄 The cure for the worst pain known to humans

🍄 Combining antidepressants and psilocybin

🍄 More positive findings from biggest psilocybin trial

🍄 Psychedelic cream?

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Why a psychedelic retreat might be the best vacation you’ve ever been on

In this episode of the Daily Mushroom Podcast, we have the CEO of Silo Wellness, Douglas Gordon. Silo Wellness offers legal, psychedelic retreats in Jamaica and Oregon. Their mission is heavily rooted in the education around the physical and mental benefits of mushrooms. We hope you enjoy this one!

Antidepressants + psilocybin

Do patients need to come off of antidepressants before trying psilocybin therapy?

New research from MindMed (MNMD) and Liechti Labs suggests that it’s not necessary – and there are actually benefits of combining the two.

Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.

More positive findings from biggest psilocybin trial

COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression. 

In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.” 

Psychedelic cream

Psycheceutical Inc., a private Florida company, is developing a unique way to deliver psychedelics – through a cream or patch applied to the back of the neck. This method allows psychedelics to enter the brain in just 5-10 minutes without entering the bloodstream, which reduces negative side effects.

Participate in psychedelic research from your phone!

Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.

The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.

It’s not too late to participate – download the app here to join the study!

Curing the worst pain known to humans

For years, Brad Badelt suffered from debilitating cluster headaches (which are often called “suicide headaches” and described as the worst pain known to humans.

After seeing countless neurologists, chiropractors, acupuncturists, and naturopaths, he would still experience the horrible headaches several times a day for weeks on end.

After taking one dose of shrooms, things finally changed. 

“When I woke the next morning, I felt different: the mental fog brought on by my cluster headaches was gone. For the next twelve months, I remained headache free. Every year since, I’ve downed a dose of shrooms, and every year my cluster headaches have remained in remission.”

Want a life-changing psychedelic trip but don’t know where to start?

The Wakeful Integration Journal is your guide to transformation. 

It’s the ultimate tool to help you prepare for, navigate, and deeply integrate your psychedelic experiences. The journal features:

  • Prompts to discover your intentions and reflect on your trip
  • Dose tracking
  • Tips to support you along the journey
  • Colouring pages to unlock your creativity

If you want to start with microdosing rather than a full-on trip, the Wakeful Intention Journal is for you! It guides you through a 6-week microdosing protocol and helps you set intentions, notice patterns, and integrate your insights.

Support the Kickstarter here to receive a journal and begin your transformation journey!

The Canadian government is funding psychedelic research!

MYND Life Sciences (MYND) received $45,600 in government funding to support a psilocybin research project on treatment resistant depression and neuroinflammation. The project will run now until March 2022.

Novamind (NM) partnered with Bienstar Wellness to develop the first network of integrative mental health clinics in Latin America. The companies plan to bring psychedelic medicine to Uruguay, Brazil, Mexico, Peru, and Panama.

PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.

Telescope Innovations (TELI) acquired the rights to the University of British Columbia’s research on synthetic psilocybin in exchange for 1M common shares at $0.99 each.

Bright Minds Biosciences (DRUG) announced that its drug discovery program has synthesized hundreds of patentable psychedelic compounds. Researchers are optimizing the most encouraging molecules and aim to announce the lead molecule early next year.

Shanti Therapeutics, a subsidiary of Global Wellness (GWS), is awaiting ethics committee approval to conduct one of the first studies on MDMA for pain management. 

These companies announced their financial highlights:

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Here’s what you missed in the legal world:

  • New Zealand is legalizing drug testing so users can check the purity of illegal substances. The services will be available at events like concerts and festivals. Read more…
  • The DEA is once again increasing the production quotas of these psychedelic drugs for 2022: 
    • Psilocybin increased from 3,000 to 8,000 grams
    • Psilocin increased from 2,000 to 3,000 grams
    • MDMA increased from 3,200 to 8,200 grams
    • DMT increased from just 250 to 3,000 grams

          The new limits will allow more researchers to study the drugs! Read more…

  • A Florida Rep. filed a bill to decriminalize all illegal substances and implement rehabilitative health intervention or civil fines instead. Read more…

Eco-friendly funerals

A startup in the Netherlands is making biodegradable “living coffins” out of mushroom mycelium!

Not only do the coffins enrich the soil, but they allow “people to become one with nature again.” 

After months of testing, the first funeral using a mushroom coffin was a success.

Bob Marley mushrooms 🇯🇲

Silo Wellness (SILO) launched a line of functional mushroom products in collaboration with Bob Marley’s family!

The Marley One line features:

  • One Mind: A coffee-flavored blend of lion’s mane and gingko biloba designed to improve focus and cognitive function.
  • One Flow: A peppermint-flavored blend of cordyceps and ginseng designed to enhance physical endurance and mental function.
  • One Harmony: A mango-flavored blend of chaga and ginger designed to stimulate gut health and improve digestion.
  • One Body: A berry-flavored blend of turkey tail and astragalus designed to support immune health.
  • One Rest: A vanilla-flavored blend of reishi and GABA designed to help reduce tension and stress and improve quality of sleep. 

Use promo code DAILYMUSHROOM20 to get 20% off! 

Shop Marley One

Industry Quick Hits

Nov 29 – Numinus (NUMI) Develops Proprietary Psychedelic Tests with New Toxicity and Potency Scans Read more…

Nov 29 – atai Life Sciences (ATAI) Increases its Ownership Position in COMPASS Pathways (CMPS) Read more…

Nov 30 – Cybin (CYBN) Announces FDA IND and IRB Approvals for Clinical Trial to Treat Frontline Clinicians with COVID-Related Distress Read more…

Dec 2 – Ketamine One (MEDI) Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD Read more…

Dec 2 – Tryp Therapeutics (TRYP) Receives Confirmation from FDA to Proceed with Phase 2a Study in Fibromyalgia  Read more…

Nov 26 – Delic Corp’s (DELC) Ketamine Wellness Centers Opening Salt Lake City & Reno Locations Read more…

Video of the Week

How LSD Triggered a Psychedelic Revolution

Playlist of the Week

Psychedelic Chill
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PharmaTher Granted New Japanese Patent for KETABET™ (Ketamine Combination Formulation), Strengthening Global Patent Portfolio

PharmaTher Granted New Japanese Patent for KETABET™  (Ketamine Combination Formulation), Strengthening Global Patent Portfolio

PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.
PharmaTher Inc.
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Win + Support + Microdose + Covid-19 🍄: issue 25

Here’s what’s in store for you in today’s issue:

🍄 Results from a global microdosing study

🍄  Ayahuasca vs. placebo

🍄 3D-printed psychedelics

🍄 Can mushrooms fight covid?

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Where Religion And Psychedelics Collide

In this episode of the Daily Mushroom Podcast, we have Peg Peters. Peg is setting up a ketamine-assisted psychotherapy clinic just outside of Vancouver, BC. He discovered psychedelics in his mid 40s, taking a 6g dose of psilocybin mushrooms while accompanied by a therapist. After that experience his career in psychedelics took off!

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Ayahuasca vs placebo

An ayahuasca retreat could make you more empathetic!

In a recent study, participants reported reduced stress, anxiety, and depression after attending an ayahuasca ceremony… even those who were given a placebo. 

However, only the ayahuasca users showed increased empathy.

The supportive group atmosphere could explain why people experienced benefits even without taking ayahuasca. 

Don’t get triggered

Researchers discovered that DOI (a psychedelic that’s similar to LSD and mescaline) can reduce anxiety and increase neural plasticity. Rats stopped showing anxious behaviours in response to fear triggers after a single dose!

How psychedelic ceremonies change your beliefs

A survey of ~900 psychedelic ceremony attendees revealed that psychedelic use is associated with a decreased belief in materialism, an increase in transcendentalism, and improved mental health. Participants showed more moderate views on metaphysical beliefs after the ceremony rather than extreme stances.

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GIVEAWAY ALERT 🚨

You could win $4,000+ in prizes for supporting legal access to psychedelics!

By becoming a member of the Canadian Psychedelic Association, you can help bring new regulations forward so Canadians in need can receive lifesaving psilocybin treatments.

If that’s not enough, you’ll also be entered to win an incredible prize package including:

  • A scholarship towards a Holos Plant Medicine retreat (Value: $1,500)
  • A 2-night stay at the Sentinel Retreat Centre (Value: $500)
  • A functional mushroom wellness package from Eversio Wellness (Value: $300)
  • 1 of 3 Physiology of Trauma premium masterclass packages from Nectara (Value: $900)
  • And more!

Plus, your membership unlocks tons of other benefits such as conference discounts, exclusive interviews, resources, and media content.

Purchase a membership before December 10th to be entered in the giveaway!

Get ready for a psychedelic TV series coming this summer!

This month’s issue of Los Angeles Magazine features an in-depth cover story on the city’s recent obsession with psychedelics. 

Now, the story is being developed into a drama/comedy series called Psychedelic City (think Silicon Valley meets Limitless).

The writer hopes the show will “wipe away some of the stigmas that have been attached to psychedelics.”

The developers are also creating a Psychedelic City metaverse platform with immersive art, music, and experimental therapies. 

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Biomind Labs (BMND) developed a new way to manufacture psychedelics using 3D printers and lasers. By printing the formulation layer by layer, the company can control exactly when the drug is released and adjust doses for each patient.

LOVE Pharma (LUV) signed a letter of intent to acquire Microdoz Therapy Inc. to accelerate a psilocybin trial for cannabis use disorder. Seems ironic considering that the company also sells THC and CBD oral strips!

Entheon Biomedical (ENBI) has begun testing the stability of its DMT formulation in preparation for a study on nicotine addiction.

PharmaTher (PHRM) applied for an orphan drug designation for a ketamine treatment for a rare seizure condition called Status Epilepticus. If approved, the designation would give the company potential tax credits, grant eligibility, and exclusive marketing rights.

Pasithea Therapeutics (KTTA) began offering an esketamine nasal spray at its UK clinics. It’s one of just three clinics in the UK that have been approved to provide the treatment.

MYND Life Sciences (MYND) began research on its biomarker test that aids in diagnosing multiple sclerosis. There are currently no physical indicators or lab tests that can diagnose the condition.

Researchers are turning to fungi to treat covid!

In an upcoming clinical trial, agarikon and turkey tail mushrooms will be given to covid-positive patients with mild symptoms. Researchers hope that the mushrooms’ antiviral and immune-boosting properties will prevent symptoms from worsening.

In a separate trial, the same blend of mushrooms will be given to subjects while getting vaccinated to see if it can boost antibody levels.

Industry Quick Hits

Nov 22 – Emyria Ltd (EMD) receives $5 million from one of Australia’s largest private investment groups Read more…

Nov 23 – Cybin (CYBN) Awards Grant for Psychedelic Treatment Clinic at Lenox Hill Hospital to Benefit Underserved Communities Read more…

Nov 23 – COMPASS Pathways (CMPS) granted fifth US patent for crystalline psilocybin Read more…

Nov 24 – Seelos Therapeutics (SEEL) Acquires Exclusive License of iX Biopharma’s Proprietary Wafer-Based Ketamine Delivery Platform Read more…

Nov 24 – NeonMind (NEON) Announces Successful Completion Of Pre-IND Consultation With FDA On Clinical Path For Obesity Drug Candidate NEO-001  Read more…

Nov 26 – Numinus (NUMI) Receives Conditional Approval to Graduate to the Toronto Stock Exchange Read more…

Video of the Week

Inside the LSD Museum That the DEA Somehow Hasn’t Nuked

Playlist of the Week

60s - 70s stoner rock
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PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher (PHRM) applied for an orphan drug designation for a ketamine treatment for a rare seizure condition called Status Epilepticus. If approved, the designation would give the company potential tax credits, grant eligibility, and exclusive marketing rights.

PDF of article

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PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

  • Adds to PharmaTher’s existing FDA orphan drug portfolio with amyotrophic lateral sclerosis and complex regional pain syndrome
  • Strengthens commitment to treat rare disorders and life-threatening conditions with ketamine
TORONTO, November 24, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Status Epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure.  The Company has received FDA ODD for ketamine to treat amyotrophic lateral sclerosis (“ALS”) and complex regional pain syndrome (“CRPS”).  The addition of SE strengthens the Company’s pharmaceutical strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.

SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and it complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, which approximately 35-45% of patients are refractory to benzodiazepines.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus.  The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine to improve quality of life and to save lives.”

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify ketamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Smoke weed with a veteran on DMT: issue 23

Here’s what’s in store for you in today’s issue:

🍄 How weed influences your trip

🍄 Healing veterans with DMT

🍄 The results from the biggest psilocybin study ever!

🍄 At-home ketamine therapy

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.

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The results from the world’s biggest psilocybin trial are in!

COMPASS Pathways’ (CMPS) stock dropped nearly 30% after announcing mixed study findings and Q3 financial results on Monday.

The company conducted a trial on 233 patients to determine the best psilocybin dose for treatment-resistant depression (TRD).

All three groups showed improvements the day after receiving the dose. The group with the largest dose had the best results, with 36.7% of patients showing at least a 50% decrease in depression scores and 29.1% in remission at week 3. A quarter of the patients showed sustained improvements until week 12.

Unfortunately, 12 patients experienced serious adverse events such as suicidal ideation or self harm, but these behaviours are common in patients with TRD.

The company is preparing for a larger trial beginning next year.

COMPASS also announced that it lost $15.8 million or $0.38 per share in Q3, an improvement compared to its $1.30 loss per share in Q3 of last year.

Here’s a graph that shows the impact on levels of depression reported by trial patients: 👇🏽

Why ketamine is so effective at preventing suicide

Researchers have known for years that ketamine can reduce depression symptoms and suicidal ideation in as little as 24 hours, but a recent study helps us understand why it’s so beneficial.

The study showed that a single dose of ketamine rapidly improved cognitive function, problem-solving abilities, and distorted thinking in suicidal patients.

“Being able to think more clearly can make someone feel less suicidal,” explains Ravi. N. Shah, MD, one of the researchers.

Ketamine was more effective than Midazolam, a benzodiazepine used as a sedative for surgeries. After the dose, suicidal ideation was diminished for up to 6 weeks.

Treating alcoholism and depression with half the dose

Cybin (CYBN) announced that its psilocybin formulation for depression and alcoholism, CYB003, could be more effective than oral psilocybin.

The company conducted preclinical testing on multiple species of animals. Researchers found that CYB003 has nearly double the brain penetration compared to oral psilocybin, resulting in a 50% reduction in dosage, variability, and onset time.

A smaller dosage has potential to reduce negative side effects such as nausea. The formulation could lead to shorter sessions which would make treatment more affordable!

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Can weed make your trip better?

A bit of weed could make your trip more spiritual and less scary.

A survey of 321 people suggests that using cannabis while on psychedelics increases the odds of mystical experiences, ego deaths, and intense visuals. 

The data also showed that low doses of cannabis reduced the chances of bad trip, whereas high doses increased feelings of fear and insanity.

Healing veterans with DMT

In honour of Veteran’s Day, we’re sharing how a Special Ops veteran cured his chronic pain and PTSD with DMT.

Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.

After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.

“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”

After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.

“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.

To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.

Insurance coverage for ketamine therapy

A major hurdle of making psychedelic therapy accessible to all will be getting the treatment covered by insurance.

That’s why we’re excited to share that Novamind (NM) has secured coverage for ketamine treatments from four major health insurance providers: Blue Cross Blue Shield, the University of Utah, PEHP Health & Benefits and MBA Benefit Administrators!

The company’s Chief Medical Officer says that this a promising signal that insurance providers are interested in more effective mental health treatments as research emerges.

Novamind has also opened a call center dedicated to insurance verification to ensure that patients are approved and reimbursed as quickly as possible.

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Congrats to the top psychedelic companies of 2021!

These leading psychedelic companies were recognized for their accomplishments at Microdose Psychedelic Insights’ Wonderland: Miami – the world’s largest psychedelic business event, ever.

Company of the Year: Cybin Inc. (CYBN)

Psilocybin Company of the Year: MycroDose Therapeutics (private)

Ketamine Company of the Year: Field Trip Health (FTRP)

Ibogaine Company of the Year: MindMed (MNMD)

DMT Company of the Year: Psilera Bioscience (private)

LSD Company of the Year: MindMed (MNMD)

MDMA Company of the Year: MAPS (non-profit)

Platform Company of the Year: MindMed (MNMD)

Drug Development Company of the Year: Awakn Life Sciences (AWKN)

Retreat of the Year: Synthesis

Clinic of the Year: Awakn Life Sciences (AWKN)

B2C Tech Company of the Year: Fireside Project (non-profit)

B2B Tech Company of the Year: MycroDose Therapeutics (private)

Try psychedelic therapy at home in these states

TripSitter Clinic Corp. now offers at-home ketamine therapy in 10 states! 

The company, which is part of Origin Therapeutics’ portfolio, expanded its services to eight new states: Arizona, Colorado, Michigan, Washington, Florida, New York, Ohio, and Virginia, in addition to California and Illinois.

Patients can receive a prescription for oral ketamine after a virtual consultation with a physician. They then take the medication at home with virtual guidance, followed by therapy sessions.

This is a promising step toward greater ketamine accessibility. 💪🏼

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Psilocybin production increases 11,900% in 2021

To keep up with the growing demand for psychedelic research, the DEA is yet again increasing the legal production quotas for certain Schedule I substances.

The original proposal for psilocybin was just 50 grams, which increased to 1,500 grams in September. The final quota is now 6,000 grams – a total increase of 11,900%!

Production of both MDMA and DMT increased 6,300% from 50 grams to 3,200 grams.

Industry Quick Hits

Nov 5 – Fluence Raises $1.6M for Psychedelic Therapy Training Read more…

Nov 5 – MAPS and Momentum Events Announce Collaboration on Psychedelic Science 2023 Read more…

Nov 8 – Blackhawk Growth’s (BLR) MindBio Therapeutics Completes Safety Milestone in its Phase 1 Clinical Trials Read more…

Nov 8 – Delic Corp (DELC) Acquisition Of Ketamine Wellness Centers Is Complete Read more…

Nov 8 – NeonMind (NEON) And SRx Health Solutions Announce Strategic Alliance To Establish Specialty Mental Health Clinics For Interventional Psychiatry Treatments Read more…

Nov 9 – MYND Life Sciences (MYND) Executes LOI to Enter into a Clinical Research Collaboration with Revitalist Read more…

Nov 9 – Nova Mentis (NOVA) Files Genetic Neuroinflammatory Disease Patent Read more…

Nov 9 – Herbal Supplement Giant, Irwin Naturals (IWINF), To Enter THC & Psychedelics Industries Read more…

Nov 11 – PharmaTher (PHRM) Announces Positive Research Results for Psilocybin Microneedle Patch Read more…

Video of the Week

DMT Quest Documentary

Playlist of the Week

60s - 70s stoner rock
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PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

  • Delivering psilocybin via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness.
  • Completing microneedle patch research programs with other psychedelics before year-end.
  • Pursuing Phase 2 clinical studies in 2022 with psilocybin and notable psychedelics.

TORONTO, November 11, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications.

The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA.

The Company’s research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.

The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) for the evaluation of the psilocybin MicroDose-MN™ patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. There can be no assurance that a definitive agreement will be entered into between PharmaTher and Revive.

The Company believes that its MicroDose-MN™ patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Psychedelic music studio changes your attachment style: issue 22

Here’s what’s in store for you in today’s issue:

🍄 Psychedelic music studio receives $4.5M in funding

🍄 How your attachment style affects your trip

🍄 First-ever study with direct psilocin

🍄 A new helmet to understand the brain

🍄 And more.

Be sure to check out last week’s Daily Mushroom podcast:

The DMT Cure for Chronic Pain and PTSD

Kieran, a retired black ops vet who magically cured his neck pain with a wild DMT trip. Kieran talks about being in a constant stress state while serving and how psychedelics help him cope with ongoing PTSD.

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First-ever study with direct psilocin

When psilocybin is consumed, it’s metabolized into psilocin, which is the compound that produces most (or all) of the psychedelic effects.

Will the experience change if psilocin is administered directly?

Filament Health (FH) just received FDA-approval for a first-of-its kind study that will reveal the answer.

The phase I trial at the University of California San Francisco will compare the effects of psilocybin and psilocin in 20 healthy patients. Psilocybin will be administered orally, whereas psilocin will be administered both orally and sublingually, meaning it will be absorbed through tissues under the tongue.

Researchers predict that direct psilocin could result in faster onset times, greater consistency and bioavailability — with fewer side effects.

A faster treatment for depressed moms

Existing treatments for post-partum depression take up to 8 weeks and often separate the mother from her baby for long periods of time, creating even more stress.

Field Trip Health (FTRP) is developing a proprietary psychedelic to change this.

The formulation, FT-104, could be administered in just one day and lasts 2-3 hours shorter than pure psilocybin. The compound leaves the mother’s system in just 24 hours, allowing her to safely breastfeed again.

FT-104 is currently in preclinical evaluation with phase I trials expected to begin in Q1 of next year.

atai accelerates schizophrenia research after promising findings

atai Life Sciences (ATAI) developed a new compound that could help treat cognitive impairment associated with schizophrenia.

The compound, RL-007, was tested on a cohort of 8 schizophrenic patients while continuing with their antipsychotic treatments. Using brain mapping and other biomarkers, researchers found that formulation improved cognition by activating receptors linked to learning and memory. 

The findings were so promising that atai decided to spend additional resources to accelerate the compound into a Phase 2a trial, which should be completed by the end of the year.

Ending the PTSD crisis

The lack of effective PTSD treatments is “a crisis,” according to the PTSD Psychopharmacology Working Group. About one in 20 people in the UK suffer from PTSD, and current treatment options are ineffective for 40% of patients.

COMPASS Pathways (CMPS) is launching a phase II trial to see if its psilocybin therapy model for treatment-resistant depression can bring relief to patients with PTSD.

The trial will assess 20 patients who experienced trauma as adults. They will be given a single dose of the psilocybin formulation followed by 12 weeks of therapy protocols.

Researchers will measure the safety of the drug as well as improvements in PTSD symptoms, functionality, and quality of life.

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Psychedelic music studio receives $4.5M in funding

When patients have a positive response to music during psychedelic therapy, they’re more likely to have a mystical experience which can lead to a more effective treatment.

That’s why neuroscientist Dr. Mendel Kaelen co-founded Wavepaths – a music studio that uses AI to create customized music—on the fly—in response to a patient’s emotional state!

The implications of Wavepaths go far beyond psychedelic therapy: hospitals, birth clinics, hospice centers, and schools are showing interest in the technology. It is already being used in 30+ countries and over 5,000 practitioners await its public release.

How your attachment style affects your trip

If you’ve ever struggled with attachment anxiety in your relationships, there’s promising evidence that psilocybin could be an effective treatment:

After undergoing individual therapy, group therapy, and a single psilocybin session, a group of 18 male AIDS survivors showed significantly reduced scores for attachment anxiety – an attachment style characterized by clinginess, fear of abandonment, and difficulty trusting others.

There were no significant changes in attachment avoidance, which is characterized by repressing emotions and discomfort with close relationships.

However, high attachment anxiety scores were associated with a greater chance of mystical experiences, whereas high attachment avoidance scores were linked to grief, fear, physical distress, and paranoia during the trip.

What better way to feel more secure in your relationships than through a trip? 🤩

Old Town Road to success

Lil Nas X was honoured as a visionary at the Wall Street Journal’s Innovator Awards after releasing his latest album, ‘Montero.’ Were magic mushrooms the secret behind his success?

The artist says that his first-ever mushroom trip was a pivotal moment while recording the album. The experience helped him reflect on himself and break free from feelings of self-consciousness.

“I was able to open up a lot. I was able to write actual stories about my life and put it into my music. I actually did that for the first time,” Nas explained.

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A new helmet to understand the brain

The LA-based company Kernel developed a brain-imaging helmet that can track what actually happens in the brain during a psychedelic trip.

The device, Kernel Flow, was just approved by the FDA to be used in a ketamine trial sponsored by Cybin (CYBN).

Researchers will use the helmet to measure the neurological activity of 15 patients during a ketamine therapy session compared to baseline activity.

Kernel Flow is much less expensive than other brain-imaging tools and allows the patients to move freely during the session.

Trip at home with a psychedelic patch

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

Creating a myriad of drugs with AI

Using an AI drug discovery program, Mydecine (MYCO) successfully added a novel psilocin analogue with improved delivery and stability to its pipeline.

The AI technology synthesizes billions of drug candidates and filters them based on psychedelic-related targets such as how they bind to receptors.

Mydecine also filed a patent for nanoemulsion technology. Nanoemulsion can:

  • help the company develop compounds inspired by traditional plant medicines such as reishi and cordyceps mushrooms
  • improve control in delivery, which is critical in microdosing and customizing dosages
  • advance development of over-the-counter consumer products
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Detroit decriminalizes psychedelics!

With a 61% to 39% win, Detroit became the fourth city in Michigan to widely decriminalize possession and therapeutic use of psychedelics.

Over 80% voted to establish a reparations committee that will address historical discrimination against Black communities through housing and economic development programs.

Industry Quick Hits

Oct 29 – Oppenheimer initiates COMPASS Pathways (CMPS) with a buy rating and $50 price target Read more…

Oct 29 – Braxia Scientific (BRAX) Announces Voting Results from the Annual General Meeting of Shareholders Read more…

Nov 1 – Blackhawk Growth’s (BLR) MindBio Therapeutics Looks to Expand Microdosing Clinical Trials Read more…

Nov 1 – Algernon Pharmaceuticals (AGN) reports positive pre-clinical data on DMT candidate to treat stroke Read more…

Nov 1 – Small Pharma (DMT) reports second quarter highlights Read more…

Nov 2 – Braxia Scientific (BRAX) Graduates First Cohort of Medical Professionals From Psilocybin-Assisted Therapy Training Program Read more… 

Nov 2 – U.S. FDA Approves Nova Mentis (NOVA) Orphan Drug Application Read more…

Nov 2 – Tryp Therapeutics (TRYP) Submits IND Application for Phase 2a Clinical Trial in Fibromyalgia Read more…

Nov 3 – Amanita Muscaria Mushroom Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada Read more…

Nov 4 – Awakn Life Sciences (AWKN) Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry Read more…

Nov 5 – Novamind (NM) Reports FY2021 Financial Results and Operating Highlights Read more…

Nov 5 – NeonMind (NEON) Biosciences Named As A Top Industry Innovator In Inaugural Issue Of Psychedelia Magazine Read more…

Video of the Week

Trippy Mushroom-Themed Resort

Playlist of the Week

60s - 70s stoner rock
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Trip at home with a psychedelic patch

PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline. PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

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