FDA receives first-ever MDMA drug application

The timeline for the Multidisciplinary Association for Psychedelic Studies (MAPS) application to reach the FDA finally reaches the starting point. Founded by Rick Doblin in 1986, MAPS commenced its inaugural clinical trial exploring the impact of MDMA on patients with post-traumatic stress disorder (PTSD) in 2004. The establishment of MAPS Public Benefit Organization in 2014, a sister entity with its prime focus on FDA approval, further marks a notable milestone. Despite the protracted journey, a crucial juncture has now been reached.

This submission signifies the first entry of a drug application for psychedelic-assisted therapy, representing a paradigm shift in psychedelic research – transitioning from a historical association with hippy experimentation to acknowledged therapeutic benefits.

The essence of MAPS PBC’s application revolves around two phase 3 studies demonstrating that patients administered three doses of MDMA achieved superior results in alleviating PTSD symptoms, as measured by a severity score, in comparison to those receiving a placebo. The more recent study disclosed a 23.7-point reduction in CAPS-5 scores for treated patients versus 14.8 points for the placebo group. Nearly half of treated patients met remission criteria after the third dose, contrasting with 21.4% of placebo recipients.

Initial follow-up data indicated that treated patients sustained improvements in symptom severity for at least six months post the third dose. Detailed findings are expected in a medical journal by the first quarter of 2024.

While the official submission represents a notable achievement, the year ahead poses additional challenges. Emerson foresees the application’s acceptance around February, triggering subsequent inspections and audits. If a priority review is granted, the FDA decision deadline could be in August.

In the event of a successful application, MAPS plans to collaborate with regulators to reclassify MDMA, currently labeled as a Schedule 1 drug with no recognized medical use and a high risk of abuse. Emerson anticipates a customary three-month interval between approval and rescheduling.

In anticipation of approval, Emerson and her team have been actively involved in state-level lobbying, acknowledging that federal rescheduling may not immediately translate to uniform acceptance across jurisdictions. Recent legislation in California allows doctors to prescribe MDMA and psilocybin once rescheduled.

Emerson envisions a surge in demand post-approval and underscores the importance of collaboration with regulators and meticulous preparation for a successful rollout. Despite the emphasis on PTSD, questions arise about the drug’s future trajectory. Emerson hints at a pivot toward addressing other trauma-based disorders, particularly eating disorders, where effective treatments are scarce, and women bear a disproportionate burden.

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