MAPS developed the first validated method of synthesizing MDMA on an industrial scale while meeting Good Manufacturing Practices. And better yet, they are placing the process in the public domain to promote scientific advances and patient access.
The 4-step process produces up to 5 kg of MDMA (or roughly 30,000 doses) with 99.9% purity.
With MDMA expected to be FDA-approved next year, this advancement comes at the perfect time to meet the growing demand for the drug 👏
Today is MAPS’ 36th birthday 🥳 See all that they’ve accomplished here.
Patients with PTSD often have eating disorders too. MDMA is known to improve self acceptance and emotional processing, so it may be the perfect treatment for both!
In MAPS’ Phase 3 trial on MDMA for PTSD, 42%* of patients scored in the “clinical” or “at-risk” range on an eating disorder scale prior to the treatment.
MDMA therapy was found to significantly reduce eating disorder symptoms in comparison to a placebo.
MAPS is commencing a multi-site Phase 2 trial this May to further examine MDMA therapy on both anorexia and binge eating.
*Patients with active purging were excluded as a precaution to avoid cardiac arrhythmias.
Update marks the first MDMA-assisted therapy session at a Numinus clinic
VANCOUVER, BC, March 30, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTCQX: NUMIF), a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that it has advanced to the next implementation phase in the clinical trial “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)” sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC), by enrolling and dosing the first clinical trial volunteer in Canada.
Numinus hosts the Canadian sites for MAPPUSX, through two purpose-designed clinics located in Montreal and Vancouver. This week, the Montreal site began drug administration, led by trial co-therapists Dr. Joe Flanders, VP Psychology, Numinus, and Dr. Emma Hapke, Staff Psychiatrist, University Health Network and Principal Investigator for the MAPS-sponsored trial. The treatment follows MAPS’ protocol of three sessions of MDMA administration and therapy, each to be followed by three integration sessions. The full program is expected to complete in mid-summer 2022.
“Numinus is excited to administer the first MDMA-assisted therapy dosing of MDMA at our clinics and contribute to the growing body of MAPS’ research,” says Dr. Flanders. “Designed with accessibility and ethics at its core, we look forward to the continuation of this study and translating the findings into clinical practice.”
MAPPUSX is an extension of MAPS’ Phase 3 studies to investigate the safety and efficacy of MDMA-assisted therapy for treating severe PTSD. The MAPPUSX trial is open to those participants from the Phase 3 studies who received the placebo drug and therapy and those who could not receive treatment due to COVID restrictions. The resulting safety data will be provided to regulatory bodies in the sponsor’s New Drug Application.
“We are proud of our clinical and research teams who have been and continue to be instrumental in driving MDMA-assisted therapy for PTSD research forward in Canada,” said Payton Nyquvest, CEO and founder, Numinus. “This week’s trial progress is another step in our strengthening collaboration with MAPS as we work together to make psychedelic-assisted therapy accessible to those in need. We will continue to work with MAPS, Health Canada and the industry to help make MDMA-assisted therapy a reality.”About Numinus
Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator. Learn more at maps.org Forward-Looking Statements
Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations & Communications, jamie.kokoska@numinus.com; Media Contact: May Lee, Communications Manager, may.lee@numinus.com
A bill that would create psychedelic treatment centers for psilocybin and MDMA therapy was approved by a legislative committee, advancing to floor consideration.
Treatments would be focused on veterans, first responders, healthcare workers, and those from underserved communities with life-threatening mental illness.
An analysis of 40 publications found that MDMA interacts with antidepressants more than psilocybin.
Taking MDMA on antidepressants could lead to toxic levels of serotonin and may be fatal, with MAOIs posing a particularly high risk.
While there is less research on psilocybin, a study from MindMed and Liechti Labs found that the SSRI escitalopram was safe to take with psilocybin, and even reduced trip anxiety.
However, the analysis found that buspirone, chlorpromazine, ketanserin, or risperidone reduced psilocybin’s subjective effects.
This helpful chart has more information on how psychedelics interact with antidepressants, but remember that this is not medical advice.
Vancouver, British Columbia, February 10, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (Frankfurt:O3X4) (OTCQB: GWSFF) (“Global” or the “Company”) and their Contract Research Organization(“CRO”) iNGENü (a fully owned subsidiary of Cannvalate Pty Ltd) sign supply agreement with Canada-based PharmAla Biotech (CSE: MDMA) to supply GMP MDMA for the Shanti Therapeutics upcoming clinical trial.
Global Wellness’ Shanti Therapeutics is a first-in-class biotech utilizing the neuromodulation properties of MDMA (aka Ecstasy) to pre-emptively treat preoperative pain. Shanti has commenced a path to their clinical trial in 22 healthy volunteers comparing the pain tolerance threshold in patients who have had exposure to a proprietary dose and formulation of MDMA. This proof-of-concept clinical study is to gauge the effect size of an increase in the pain threshold in subjects who have been pre-emptively treated with MDMA. iNGENü was chosen as the Contract Research Organization (CRO), as they are a niche CRO specialized in novel psychedelic clinical trials.
“Biotechs face many roadblocks as a drug development journey begins. Choosing the right CRO can make or break a molecule’s future and a bad selection can derail the most aggressive clinical trial. Developing an integrated, big-picture roadmap for a molecule and company can only work with a formidable CRO, as even a lucrative discovery is a challenging and expensive endeavor. Not only do we have both a strong CRO to guide the research and trials plus the recently formed alliance with PharmAla, but also another Canadian partner Pharmascience Inc. completes their MDMA orders, which is Canada’s second largest manufacturer of generic and branded drugs and a tremendous milestone check mark for Shanti! These strategic partnerships are pivotal to the success of Shanti as the sponsor of the project and the discovery of a new molecule to solve the puzzle of chronic pain.” Said Meris Kott, CEO Global Wellness Strategies Inc.
“I’m thrilled that, as the first company to develop a full GMP MDMA value chain in North America, we can now help enable other companies such as Global Wellness Strategies,” Said Nick Kadysh, founding CEO, PharmAla Biotech. “Alleviating the backlog of clinical-grade MDMA for research will accelerate the entire Psychedelics category, and help bring MDMA in the mainstream. Over the coming months we will be working diligently to fulfill Global Wellness Strategies’ needs, and support them as they move their research forward.”
PharmAla Biotech Holdings Inc. (CSE:MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation.
About Global Wellness Strategies
Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.
Further information about the Company is available on www.SEDAR.com under the Company’s profile.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute “forward–looking statements” or “forward-looking information” (collectively “forward-looking information”) as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “anticipates” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the 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. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.
Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program
VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific drugs for approved patients who have not responded to other available treatment options.
The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psilocybin and MDMA that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psilocybin and MDMA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.
“While we will continue to advance the research of psychedelic-assisted psychotherapy through our clinical trials and drug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psilocybin and MDMA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
Following the addition of psilocybin and MDMA to Health Canada’s SAP in January, Mydecine launched its Special Access Support and Supply Program for physicians, clinics and hospitals throughout Canada, providing access to cGMP products, protocol training, therapy manuals, and technology to ensure safe and effective therapy outcomes for patients.
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
For more information, please contact: Media Contact Morgan Kervitsky, Director of Marketing pr@mydecineinc.com
Investor Relations Morgan Kervitsky, Director of Marketing contact@mydecineinc.com
On behalf of the Board of Directors: Joshua Bartch, Chief Executive Officer contact@mydecineinc.com
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
A couple was on the verge of getting divorced until they took MDMA together for the first time.
The wife, Ree, said her husband couldn’t open up to her or deal with conflict, but MDMA helped them see eye-to-eye.
“My husband started sharing with me for the first time all these thoughts and emotions,” Ree said. “It was him without the walls.”
They decided to take MDMA together twice a year and go over a list of issues they want to address. Three years later, their marriage is solid and they can communicate openly without the need for drugs.
A recent study found pure MDMA administered in a clinic does not have the “come down” effect that recreational users often report the day after dosing.
Participants maintained a positive mood during the week following the dose. Plus, no participant had used or desired to use illegal MDMA at the 3 month and 6 month follow ups.
The Innovation Passport will make MDMA therapy for PTSD widely available in the UK, as rapidly as possible!
The Multidisciplinary Association for Psychedelic Studies (MAPS) found that 88% of patients had a reduction in PTSD symptoms after three MDMA sessions in conjunction with trauma-focused therapy.
The organization was granted an Innovation Passport for the treatment – a UK designation that speeds up the timeline for approval of innovative medicines for life-threatening conditions (similar to Breakthrough Therapy Designations in the US, which the treatment received in 2017).
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checkbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
