The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy, according to the company seeking approval.
The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dashing the hopes of many Americans with intractable mental health conditions who are desperate for new treatments.
According to Lykos Therapeutics, the company that had sought approval for the treatment, the agency said there was insufficient data to allow its use. The company said that the F.D.A is requesting an additional clinical trial, to continue to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.
Had it been approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities.
Outright approval by the F.D.A. would have been a watershed moment in the decades-long effort by researchers to demonstrate the healing potential of compounds like LSD and psilocybin, the psychoactive component of so-called magic mushrooms.
“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.
But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and rejected the company’s application. With regard to two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that its benefits did not outweigh the risks.