MDMA Therapy for PTSD Rejected by FDA Panel

MDMA therapy, which has been considered promising in PTSD treatment, has been rejected by a Food and Drug Administration (FDA) advisory committee, which cited concerns about the background research involving the use of the controversial psychedelic drug in its rejection.

NPR reports that the panel made its decision on Tuesday, June 4, claiming that the research surrounding MDMA use failed to show the drug’s efficacy in post-traumatic stress disorder treatment. What’s more, the FDA panel determined in a 9-2 ruling that talk therapy, combined with the use of the drug, is not effective in treating PTSD, and voted 10-1 that the risks of the drug far outweigh the benefits.

This puts the drug, which was sponsored by Lykos Therapeutics, in jeopardy of receiving final approval by the governmental body.

“It seems like there are so many problems with the data,” said Melissa Barone, one of the panelists and a psychologist with the VA Maryland Health Care System, according to the outlet. “Each one alone might be okay, but when you pile them up on top of each other…”

“I have real concerns with the validity of the data and the allegations of misconduct,” agreed Elizabeth Joniak-Grant, a sociologist and a member of the FDA panel. “I can’t in good conscience support something where these many harms are being reported.”

Better known by its street name, ecstasy, or molly, MDMA is classified as an illegal drug by the United States Drug Enforcement Agency (DEA). When abused, MDMA can compromise the body’s ability to regulate its temperature, leading to nervous system failure, brain swelling, and even death.

A Lykos executive, however, urged the panel to consider the positive effects of the drug on PTSD patients while also acknowledging its potential for abuse.

“In totality, these results support [that] MDMA in combination with psychological intervention provides significant and meaningful reductions in PTSD symptoms and functional impairment in patients with PTSD,” said Berra Yazar-Klosinski, chief scientific officer for Lykos.

The FDA panel’s rejection of the drug, however, does not mean that there will be no FDA approval. For example, Guardant’s blood test for colorectal cancer recently got approval from an FDA advisory board, but to date, it has not been approved by the governmental agency.

That said, it may prove difficult to get MDMA approval from the FDA.