Novel PTSD Treatment Advances Towards FDA Approval
MMS Holdings (MMS), an award-winning, data-focused contract research organization (CRO), announced today that it has been selected by MAPS Public Benefit Corporation (MAPS PBC) as its contract research organization 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 as the confirmatory Phase 3 trial MAPP2, the second of two Phase 3 trials conducted by MAPS PBC, finished enrollment in early May.
MAPP1, the first of two Phase 3 trials conducted by MAPS PBC of investigational MDMA-assisted therapy, showed that 88% of participants experienced a mean 44.7% (24.4 point) reduction 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 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,” says 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 its 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,” says Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer at MAPS PBS.
“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,” says Dawn McCollough, Chair, MAPS PBC Board of Directors.
The 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. 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 commonly comorbid conditions 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. To learn more about this potential treatment for PTSD, visit maps.org.
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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