FDA Rejects MDMA as PTSD Treatment, Demands Further Research

FDA's Decision

On Friday, the Food and Drug Administration (FDA) declined to approve MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD), citing a lack of sufficient evidence.

Independent Panel's Recommendation

This decision follows the recommendation of an independent advisory panel, which voted 14-1 against approving MDMA therapy for PTSD.

Need for Further Research

The FDA stated that while MDMA has shown promise in early studies, larger and longer-term trials are needed to fully evaluate its effectiveness and safety.

Lykos Therapeutics' Disappointment

The decision was a major setback for Lykos Therapeutics, the drugmaker that has been developing MDMA therapy for PTSD. Lykos had raised over $100 million in anticipation of FDA approval.

Continuing Development

Despite the FDA's rejection, Lykos stated that it will continue to develop MDMA therapy and plans to conduct additional research to address the agency's concerns.

Implications for PTSD Treatment

The FDA's decision leaves patients with PTSD without a new treatment option, highlighting the need for continued research into novel therapies for this condition.