FDA Receives NDA From MAPS PBC Regarding MDMA-Assisted Therapy For PTSD

The moment that many psychedelic participants and investors have waited for has finally arrived. Today, MAPS Public Benefit Corporation (MAPS PBC) has formally communicated the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA (capsules) in conjunction with MDMA-assisted therapy. This intervention includes psychotherapy, colloquially known as talk therapy, along with additional supportive services administered by qualified healthcare providers.

The focus of this investigational MDMA-assisted therapy is the treatment of post-traumatic stress disorder (PTSD), and upon approval, it would mark a groundbreaking milestone as the inaugural psychedelic therapeutic and protocol sanctioned for PTSD.

The NDA submission encompasses findings from various studies, notably two randomized, double-blind, placebo-controlled Phase 3 trials—MAPP1 and MAPP2—assessing the efficacy and safety of MDMA-assisted therapy in comparison to a placebo complemented by therapy.

These studies, conducted on participants diagnosed with moderate or moderate and severe PTSD, successfully achieved their primary and secondary endpoints. The outcomes of MAPP1 and MAPP2 were previously documented on a peer-reviewed basis in Nature Medicine, a Tier-1 medical journal.

Having been granted Breakthrough Therapy designation in 2017, MAPS PBC has formally petitioned the FDA for Priority Review of the NDA. The FDA is mandated to make a determination within 60 days regarding the acceptance of the NDA for review, specifying whether it qualifies for priority or standard review, with the latter spanning six or ten months. Should the FDA grant approval, the subsequent step would involve the U.S. Drug Enforcement Administration (DEA) rescheduling MDMA, thereby facilitating its availability for prescription medical use.

Phase 3 results of both the MAPP1 and MAPP2 studies have previously met the primary endpoint, gauged by the alteration from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), as well as the key secondary endpoint reflecting the enhancement in functional impairment linked to PTSD. This improvement was quantified by the change from baseline in the Sheehan Disability Scale (SDS).

Also noteworthy is the absence of any reported serious adverse events in the MDMA group across both studies, which reaffirmed the therapy’s safety profile.

Of note: MDMA-assisted therapy remains unauthorized by any regulatory agency, with the safety and efficacy for PTSD treatment yet to be officially established. Concurrently, investigations into the potential applications of investigational MDMA-assisted therapy in alternative indications are actively underway.

TDR will have full coverage of subsequent outcomes pertaining to upcoming FDA decisions as events warrant.

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