The U.S. Food and Drug Administration (FDA) has declined to approve MDMA, commonly known as ‘ecstasy’, as a treatment for post-traumatic stress disorder (PTSD), according to a statement from drug maker Lykos Therapeutics.
The decision follows a recommendation by an independent advisory committee in June, which concluded that there was insufficient evidence to prove the therapy’s safety and effectiveness.
Experts and advocates have described the decision as a minor setback in the expanding movement to use psychedelics for treating certain mental health conditions.
The FDA had faced political pressure to approve the drug, which would have been the first new treatment for PTSD in over two decades.
Lykos Therapeutics had requested FDA approval for MDMA to be used as part of a treatment regimen in combination with talk therapy. However, the advisory committee cited numerous concerns, including poorly designed studies, allegations of sexual misconduct during a mid stage clinical trial, and potential serious health risks associated with the drug, such as heart problems and abuse.
A review by FDA scientists, published before the June meeting, also raised concerns about the conduct of the trials, noting that some patients and therapists were likely able to discern whether they were receiving the actual medication or a placebo.