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


Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, talks about some of the problems he saw during the Psychopharmacologic Drugs Advisory Committee meeting.

The Psychopharmacologic Drugs Advisory Committee voted against the use of midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) during a meeting held last week. The independent FDA advisory panel, which met to discuss a new drug application (NDA) from Lykos Therapeutics, voted 9-2 that MDMA-assisted therapy to treat PTSD is not effective and 10-1 that the benefits do not outweigh its risks.

Much of the meeting’s discussion centered on 2 randomized, double-blind, placebo-controlled phase 3 trials conducted by Lykos. Members of the panel raised concerns about the occurrence of functional unblinding in the 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.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, said that he was disappointed in the panel’s overall decision. In an interview with Drug Topics, Clark discussed problems that he saw with the panel, the issue of functional unblinding, stereotypes of psychedelics being gateway drugs, and the fact that patients with PTSD desperately need new treatment options.

“There was a statement made by the panel chair, that in his opinion, people would go home after receiving this potentially life-saving therapy and then take cocaine and alcohol with their significant others,” Clark said. “To me, that clearly is just repeating stereotypes of psychedelics as gateway drugs. It was not supported by any of the data presented at the meeting and it was not supported by any of the data in the literature. And it seriously calls into question how well this panel was actually qualified to even comment on this therapy at all.”


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