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MDMA-Assisted Group Therapy for PTSD Among Veterans Study Will Proceed Following Successful Safety Negotiations

MDMA-Assisted Group Therapy for PTSD Among Veterans Study Will Proceed Following Successful Safety Negotiations

  • The FDA lifted the clinical hold from a MAPS-sponsored Phase 2 study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder among veterans at the VA Portland Health Care System
  • This essential proof-of-principle study tests safety and logistics of group therapy, the first step in fully investigating the treatment for efficacy and broader patient access
  • The data-driven negotiation strategy included substudies of participants’ no-overnight stay conducted in the first Phase 3 trial of MDMA-assisted therapy for PTSD

After months of negotiations with the U.S. Food and Drug Administration (FDA), the Multidisciplinary Association for Psychedelic Studies (MAPS) has been permitted to initiate the MAPS-sponsored Phase 2 Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder (PTSD) in Veterans (MPG1). Despite its status as the world’s leading research center for PTSD, few Veterans Affairs (VA) facilities have hosted clinical trials of MDMA-assisted therapies for PTSD. 

Though the study was approved by the VA Portland Health Care System Institutional Review Board months earlier, the FDA placed a partial clinical hold due to a theoretical safety concern surrounding a perceived need for overnight stays at the trial location, a requirement that was not part of the proposed study protocol. In response to the clinical hold, MAPS submitted safety data from a Phase 3 sub-study; the FDA agreed to lift the clinical hold on June 15, 2022.

In the early Phase 2 studies, we included overnight stays as an opportunity for the participants to rest and integrate what unfolded during their MDMA-assisted therapy session. Though we had no data to suggest there was a concern about safety overnight, these stays became required from the FDA perspective. In the Phase 3 program, we’re collecting safety data from participants with and without overnight stays to gather evidence to whether overnight stays are necessary. From the data we have so far, that doesn’t seem to be the case. We are pleased that the safety data in the Phase 3 substudy without overnight stays could support the FDA in making the data driven decision to permit no overnight stays in this important group study research.

Allison Coker, Ph.D., Associate Director of Regulatory Affairs, MAPS PBC

The study is conducted by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, led by Chris Stauffer, M.D., and hosted within the VA Portland Health Care System. Eighteen Veterans in three cohorts of six will undergo the first of two MDMA-assisted therapy sessions individually and the second treatment session in their group cohort, along with individual and group preparation and integration sessions. If MAPS’ appeal was not granted, each cohort of six Veterans would have been obligated to stay overnight in the VA hospital after their MDMA-assisted therapy sessions. 

There is so much yet to explore regarding the relational potential of MDMA-assisted therapy, and research on group therapy combined with MDMA sessions is a logical next step. What drives this work for me are the unique therapeutic properties of group cohesion that I’ve witnessed in my previous group therapy trials with oxytocin and psilocybin. If the FDA finds MDMA-assisted therapy to be safe and effective, the benefit of the group model for scalability and access could be an added bonus. My team and I are grateful that the FDA is permitting our innovative MDMA-assisted group therapy protocol, including sending Veterans home after MDMA sessions with a pre-screened and informed support person, to proceed.

Chris Stauffer, M.D., Principal Investigator for MPG1

The first Phase 3 trial of MDMA-assisted therapy for PTSD achieved encouraging results among participants with severe, chronic PTSD: two months after the final experimental session, 88% of participants experienced a ≥10 point reduction in PTSD symptoms and 67% no longer met the criteria for a diagnosis of PTSD. MDMA may be an effective catalyst for other therapy modalities commonly used in the treatment of PTSD. MAPS PBC is collaborating with experts in these modalities, trained through the MDMA Therapy Training Program, to explore the potential of other treatments through proof-of-principle studies such as MPG1. Group therapy, which can be a highly effective treatment for people with common experiences, may also be highly effective at reducing costs for patients. If this trial indicates the treatment may be safe and effective, further research of group therapy will be pursued as one element of MAPS’ comprehensive patient access and health equity programs.   

NOTE
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy.

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ABOUT MAPS
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 MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.

ABOUT MAPS PUBLIC BENEFIT CORPORATION
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, commercialization, and patient access of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. MAPS PBC is the parent company of MAPS EU, formed to organize and administer clinical trials of investigational MDMA-assisted therapy for PTSD in the United Kingdom and European Union.

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Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration

Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration

  • On PTSD Awareness Day, MAPS PBC announces plans to develop the New Drug Application for MDMA-assisted therapy in collaboration with MMS Holdings
  • The second Phase 3 trial of the Breakthrough-Designated Therapy for PTSD will be completed in late 2022, with a targeted NDA submission in 2023 supported by MMS Holdings
  • MMS Holdings was selected for extensive experience supporting neuroscience-related and first-in-class NDAs

MAPS Public Benefit Corporation (MAPS PBC) announced today that it has selected MMS Holdings (MMS), an award-winning data-focused contract research organization (CRO), as its CRO for the development of a New Drug Application (NDA) for MDMA-assisted therapy for posttraumatic stress disorder (PTSD). This announcement comes on PTSD Awareness Day and follows MAPS PBC’s May milestone: completing enrollment for the MAPP2, the second, confirmatory Phase 3 trials.

MAPP1, the first of two Phase 3 trials conducted by MAPS PBC to evaluate investigational MDMA-assisted therapy for the treatment of PTSD, showed that 88% of participants experienced a clinically significant reduction (≥10 points) in PTSD symptoms two months after the last experimental session, with no serious safety signals emerging. In addition to being granted Breakthrough Therapy designation, MDMA-assisted therapy has the potential to  become the first-in-class FDA-approved psychedelic-assisted therapy.

MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project management support.

Part of our mission at MMS is using our decades of experience to bring life-changing therapies to positively improve patient lives worldwide. While PTSD was identified decades ago, we remain woefully behind with therapeutic treatment options. This collaboration with MAPS PBC and their groundbreaking therapy may change the course of PTSD treatment and could greatly impact those with the disorder.

Uma Sharma Ph.D., Chief Scientific Officer at MMS

MMS brings decades of experience developing new drug applications, averaging support for 8 to 12 annually and specializing in first-in-class and other challenging submissions with their creative approach. Since inception, MMS sponsors have not received a refusal to file or a complete response letter, giving MAPS PBC the confidence that a successful submission dossier will be submitted to the FDA.

MAPS PBC is excited to work with a Contract Research Organization like MMS that has years of neuroscience and regulatory submission experience.Together, we can work towards gaining FDA approval and bringing this treatment to patients and families who may greatly benefit from it.

Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer at MAPS PBC

Reaching completion of enrollment for the second Phase 3 study is an extraordinary achievement for this program and one step closer to submission of the NDA.  I am confident that collaboration with MMS will lay the groundwork for a high quality regulatory submission.

Dawn McCollough, Chair, MAPS PBC Board of Directors

This announcement comes on PTSD Awareness Day, observed annually to educate people about PTSD and its symptoms, reduce stigma toward people with mental injuries, and bring hope for improved treatments. It is estimated that more than 350 million people, including 12 million Americans, are estimated to experience PTSD from accidents, war, interpersonal violence, or other causes. Yet underdiagnosis is common, particularly among marginalized populations. PTSD may be misdiagnosed as a commonly comorbid condition such as anxiety, depression, or substance use disorder. While some first-line treatments are effective in the treatment of PTSD or its symptoms, dropout rates may be high or the treatments might have limited effectiveness for certain causes of trauma. 

NOTE 
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy. 

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ABOUT MMS
MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Visit mmsholdings.com to learn more.

ABOUT MAPS
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 MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, commercialization, and patient access of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. MAPS PBC is the parent company of MAPS EU, formed to organize and administer clinical trials of investigational MDMA-assisted therapy for PTSD in the United Kingdom and European Union.

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MAPS under fire for alleged investigator misconduct

MDMA trials under review in Canada over alleged abuse of study participants

Health Canada is reviewing all previously approved MDMA trial applications after a former trial participant came forward with sexual assault allegations.

Footage from MAPS’ PTSD trial in 2015 shows patient Meaghan Buisson being physically restrained and spooned by two therapists (one of them unlicensed) during an MDMA therapy session.

The session was recorded to ensure that therapists were following treatment protocols, but the footage wasn’t actually reviewed for 6 years. MAPS is finally looking into recordings from all past patients.

“I just want people to realize, this is not against MDMA. This is not against psychedelics,” Meaghan ensures.

“I’m just saying that if this drug is going to be legalized and medicalized in this way, then there is a certain degree of safety and fiduciary responsibility and credibility that goes into being part of the medical system — and especially with vulnerable subjects.”

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Canadian Senator microdoses for depression

Canadian Senator Admits He Takes Psilocybin for Depression

In his opening speech at the Catalyst Psychedelics Summit, Canadian Senator Larry Campbell shared his fascinating (yet slightly disturbing) experience with microdosing.

The 74-year-old politician had been suffering from depression and PTSD for ages when his mental health suddenly started improving out of nowhere.

When Larry told his wife the good news, she admitted that she’d been spiking his morning coffee with a bit of psilocybin for the past two weeks 😲

While we don’t condone drugging people without their knowledge, her experiment revealed some important anecdotal evidence – the benefits that Larry experienced must have been from the psilocybin itself and not a result of the placebo effect!

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Equity initiatives for PTSD treatment

MAPS Completes Enrollment, as Planned, for the Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD

MAPS announced that its Phase 3 MDMA trial for PTSD is now fully enrolled at 13 sites across the United States and Israel.

The organization took equity initiatives to ensure that BIPOC and LGBTQ+ individuals are represented in the study, as these individuals are more likely to have PTSD (yet less likely to be diagnosed or have reasonable access to treatment).

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Participate in psychedelic research

If you’ve been wanting to try psychedelic therapy legally, now’s your chance!

Johns Hopkins is recruiting participants for a number of psilocybin studies on:

Plus, Nova Mentis is recruiting both autisitc and neurotypical patients for an observational study that will lead to a psilocybin microdosing study.

If you want to contribute to psychedelic research from home, check out Johns Hopkins’ online surveys on psychedelics and breathwork for anxiety, depression, and PTSD.

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“It’s been 50 years since the war and I finally came home”

GoDaddy Billionaire Bob Parsons Believes Psychedelics Can Heal Trauma—And He’s Putting His Money (And Brain) On The Line

Bob Parsons, founder of GoDaddy, suffered from PTSD after witnessing “grisly combat” in the Vietnam War. 

It wasn’t until he went through a multiday therapy treatment with psilocybin, ayahuasca, and LSD that he began to feel like his old self again. 

“What I think psychedelics did was a reset. Now, I’m like people who haven’t been in combat to a certain degree,” he believes. 

Bob is on a mission to help other veterans battling PTSD. He donated $5M to Mount Sinai’s psychedelic research center to fund MDMA therapy training for healthcare practitioners. 

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MDMA treatment helped save my life

“MDMA Treatment Helped Save My Life”

“I am a completely different person then versus now. My PTSD will always live inside of me, but it’s no longer taking over my life,” says Sarah, one of the participants in MAPS’ MDMA trial.

Sarah endured a traumatic sexual assault that gave her painful flashbacks. 

Over three MDMA therapy sessions, she was able to go back to the experience and fill in the gaps in her memory to fully process what had happened in a safe environment. In the final session, she confronted her attacker and was able to find forgiveness for them. 

“I felt like I was given freedom from the trauma,” she explains.

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Numinus Completes First MDMA Administration in PTSD Trial Sponsored by MAPS

Numinus Completes First MDMA Administration in PTSD Trial Sponsored by MAPS

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. 

Learn more at numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.About MAPS

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