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.
###
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.