Much anticipated FDA decision about psychedelics for PTSD ends with denial

The U.S. Food and Drug Administration declined to approve midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder on August 9, issuing a Complete Response Letter to the drug maker Lykos Therapeutics. The decision followed a closely watched review of the psychedelic treatment and therapy for PTSD.

Study at a glance

Abstract

In a closely watched decision involving the use of psychedelic treatment and therapy to treat post‐traumatic stress disorder (PTSD), the U.S. Food and Drug Administration (FDA) on Aug. 9 declined to approve the use of midomafetamine (MDMA)‐assisted therapy for the disorder. The federal agency issued a Complete Response Letter (CRL) for MDMA‐assisted therapy to its drug maker, Lykos Therapeutics.