FDA declines to approve novel MDMA therapy to treat PTSD

The U.S. Food and Drug Administration (FDA) has decided not to approve the use of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD). According to Lykos Therapeutics, the company behind the drug, the FDA has requested an additional Phase 3 trial to further assess the treatment's safety and effectiveness.

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Lykos initially submitted promising data from two late-stage clinical trials, where approximately 200 participants with PTSD underwent MDMA-assisted therapy. This therapy involved three eight-hour MDMA sessions, each spaced about a month apart, and additional talk therapy sessions.

MDMA, a psychoactive drug that promotes emotional openness, is currently classified as a Schedule I substance, meaning it’s considered to have no accepted medical use and a high potential for abuse. Reclassifying it would require significant changes involving multiple federal agencies.

In June, an independent FDA advisory committee overwhelmingly voted against approving the treatment. The committee raised concerns about the integrity of the trial data, particularly around safety and potential bias in efficacy results. The committee also noted the difficulty in determining how much of the treatment's success was due to the accompanying talk therapy, which the FDA does not regulate.

Safety concerns were also highlighted, especially regarding MDMA’s potential for abuse and its effects on heart and liver health. The FDA found that the trials did not adequately assess these risks.

Lykos Therapeutics has stated that conducting the additional trial could take years but is confident it can address the FDA's concerns. The company plans to seek a meeting with the agency to discuss the next steps and potentially resubmit the application.

The decision has sparked mixed reactions. Public Citizen, a consumer advocacy group, praised the FDA’s caution, emphasizing the need for rigorous evidence before approving new drugs. However, some veterans' groups expressed disappointment, arguing that the FDA could have conditionally approved the treatment with strict safety measures in place.

Veterans who suffer from PTSD and are interested in MDMA-assisted therapy may now need to seek treatment outside the U.S. or through underground providers, which these groups see as a tragic outcome.