An FDA panel recommended against approving MDMA to treat post-traumatic stress disorder.
At a June 4 meeting, the Psychopharmacologic Drugs Advisory Committee voted 9-2 that midomafetamine in combination with talk therapy is not shown to be effective for treating PTSD based on available data. The committee also voted 10-1 that the benefits of the treatment do not outweigh the potential risks, according to a June 4 news release from Lykos Therapeutics.
The therapy, developed by Lykos Therapeutics, was the first new PTSD treatment evaluated by the FDA in 25 years.
Amy Emerson, CEO of Lykos Therapeutics, said the company was disappointed in the vote.
"We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved," Ms. Emerson said in the statement.
Final trials conducted by Lykos showed MDMA, also known as ecstasy, was effective in reducing PTSD symptoms when used alongside talk therapy, according to a September report from The New York Times.
FDA staff and members of the advisory committee expressed concerns with the validity of these clinical trials of MDMA-assisted therapy, NPR reported June 4. Critics expressed concerns Lykos Therapeutics may have pressured study participants to not report adverse effects, according to Politico.
The advisory committee was also concerned about the effect of expectation bias on the trial, according to Politico. Because of the psychedelic effects of MDMA, patients in a double-blind study can typically discern whether they received the drug or not, which can make participants more likely to say the drug was beneficial.
The FDA does not have to follow the recommendations of advisory panels, but usually does, Politico reported. The agency is expected to issue a final decision in August.