FDA rejects ecstasy treatment for PTSD

Zoom out: The FDA followed the June recommendation of an advisory panel that overwhelmingly voted against the new drug application from Lykos Therapeutics.

• The advisors cited missing safety data, allegations of misconduct in clinical trials, and difficulty teasing apart how much of the reported benefits stem from the drug versus the accompanying psychotherapy.
• But a vocal group of veterans groups, lawmakers, billionaire investors and other advocates argued there was scientific proof of the effectiveness of MDMA-assisted therapy to treat PTSD and urged regulators to approve the treatment.

What they're saying: The FDA said it is responsible for ensuring drug safety and efficacy, and the data on this therapy had limitations.

• "The agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD. We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs," a spokesperson said.

What's next: Lykos said in a statement that it plans to request a meeting with the FDA to ask the agency to reconsider the decision and further discuss its recommendations.