The Food and Drug Administration has rejected an application to approve MDMA for treating post-traumatic stress disorder in adults, saying more research is needed to determine its safety and efficacy.
The FDA on Friday sent a “complete response letter” to Lykos Therapeutics, the company established to develop and promote therapy using the psychedelic drug, denying approval based on concerns expressed in June by a federal advisory panel on the scientific studies of the treatment.
The panel had said the way the trials were conducted and assessed may have inflated results and raised additional questions.
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The FDA agreed, saying in a statement that “significant limitations to the data contained in the application” prevented the agency from issuing conditional approval.
“The agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD,” the FDA wrote. “We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.”
The announcement is a blow to advocates, lawmakers and veterans who pushed for approval. In the weeks leading up to the FDA decision, a bipartisan group of 80 lawmakers and more than a dozen advocacy groups said the therapy was needed, given there…
