As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?

The FDA’s decision on a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) is quickly approaching, with a Prescription Drug User Fee Act (PDUFA) date set for August 11. The agency’s verdict has been highly anticipated and could mark a historic shift in psychedelic medicine, as it would be the first psychedelic-assisted therapy approved in the United States.

The NDA from Lykos, which was granted priority review, was supported by data from 2 phase 3 clinical trials: MAPP1 (NCT03537014) and MAPP2 (NCT04077437). The randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of MDMA used in combination with psychological intervention versus placebo in patients diagnosed with severe or moderate to severe PTSD. Both studies found that MDMA-assisted therapy induced significant and robust attenuation in PTSD symptoms.

READ MORE: Discussing the FDA Panel’s Rejection of MDMA-Assisted Therapy for PTSD

However, despite the positive data, an independent FDA advisory panel voted against the use of MDMA for PTSD during a meeting held in June. Members of the Psychopharmacologic Drugs Advisory Committee raised concerns about the occurrence of functional unblinding in the 2 studies, as well as adverse events that occurred, particularly around cardiovascular effects from the drug. Committee members also cited the lack of data on the potential for abuse as a major issue. The vote dealt a blow to proponents of psychedelic medicine, putting the potential approval of the first psychedelic in jeopardy.

In an interview with Drug Topics, Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discussed how MDMA's approval would impact the current landscape of mental health treatment, how it could affect public perception and stigma surrounding psychedelic drugs, if an approval could set a precedent for other psychedelic therapies, and how the psychedelic therapy community would be impacted if the FDA declined approval.

“If MDMA is approved by the FDA, and we’re cautiously optimistic that it will be based on the strength of the data, this represents a paradigm shift,” Clark said. “Not only is it the first in a class of psychedelic treatments, but it’s the first new treatment for PTSD in over 2 decades. Now, this is big because there are over 13 million Americans suffering from PTSD right now and statistics show that between 17 and 22 veterans commit suicide every day. We desperately need more treatments…It would bring hope to those millions of patients who have had no good options for the last several decades.”

READ MORE: FDA Updates

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