FDA Denies Approval for MDMA-Based PTSD Treatment

The U.S. FDA has rejected the approval of a therapy based on MDMA for post-traumatic stress disorder (PTSD) patients, citing insufficient data. Lykos Therapeutics, the developer, announced the rejection. MDMA, known as ecstasy or molly, has been proposed by advocates for therapeutic use in mental health.

In a recent decision, the U.S. Food and Drug Administration (FDA) declined to authorize the first MDMA-based treatment for post-traumatic stress disorder (PTSD). The decision was announced by Lykos Therapeutics, the company behind the therapy, stating that the data submitted was deemed insufficient for approval.

MDMA, commonly recognized as ecstasy or molly, has long captured the interest of proponents who believe it holds promise for treating mental health disorders. These advocates point to its potential therapeutic applications beyond its well-known recreational use.

This development marks a significant moment in the ongoing debate around the medicinal use of psychedelics in clinical settings, particularly for mental health therapies.

(With inputs from agencies.)