FDA Says No to MDMA as Therapy for PTSD

MONDAY, Aug. 12, 2024 (HealthDay News) — Advocates for the use of the psychedelic drug MDMA (midomafetamine) to treat mental health conditions were delivered a setback on Friday after the U.S. Food and Drug Administration declined to approve it as treatment for post-traumatic stress disorder (PTSD).

There is insufficient evidence that MDMA — currently illegal and also known as Ecstasy or molly — can ease PTSD, the agency told Lykos Therapeutics, a company that”s been seeking to gain approval for the drug”s legitimate use.

The FDA asked that Lykos conduct another clinical trial to determine whether MDMA is safe and effective against PTSD — a demand that could mean many years and millions of dollars before another chance at approval would arise.

“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Lykos Therapeutics CEO Amy Emerson said in a statement.

“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the [agency”s] advisory committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson added.

Many had assumed that FDA approval was assured, given that Lykos” trials had been designed in consultation with the agency.

The company trial involved 100 people who had been diagnosed with PTSD for an average of 15 years.

However, the decision was not a complete surprise: An FDA advisory board that met in June decided against recommending MDMA as treatment.

If it had been approved, the drug would have been the first psychedelic drug regulated by federal authorities.

“This is an earthquake for those in the field who thought FDA approval would be a cinch,” Michael Pollan, co-founder of the UC Berkeley Center for the Science of Psychedelics, told the New York Times. He”s also the author of the best-selling “How to Change Your Mind,” a book that”s helped alter public attitudes towards psychedelics in general.

Key to the FDA”s rejection of MDMA is the fact that Lykos” trials did not address the level of cardiac risk tied to the drug”s use.

Some benefit did seem to be there: According to company data, more than two-thirds of patients with PTSD at the beginning of the clinical trial no longer qualified for such a diagnosis just six months after beginning treatment.

Overall, 86 percent of participants who received MDMA combined with psychotherapy saw symptoms subside, and 71 percent no longer met criteria for PTSD by the study”s end. That”s compared to 48% of people who took a placebo alongside their talk therapy.

For years, people battling the flashbacks and anxiety of PTSD have been going abroad to seek out the controversial treatment.