Lykos Therapeutics: FDA Set to Review MDMA for PTSD Treatment

FDA to review MDMA on June, potentially marking a breakthrough for psychedelic-assisted therapy in the U.S.

The U.S. Food and Drug Administration is set to meet June 4 to review Lykos Therapeutics’ new drug application for midomafetamine (MDMA) as a new treatment for post-traumatic stress disorder.

If approved, it would be the first new PTSD drug in 25 years, Lykos said in a May 6 news release.

“This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy,” said Lykos Therapeutics CEO Amy Emerson. “We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD.”

The FDA’s Psychopharmacologic Drugs Advisory Committee will review results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of MDMA used in combination with psychological intervention, which includes psychotherapy and other supportive services provided by a qualified healthcare provider. The FDA will compare the results to a placebo with psychological intervention in participants diagnosed with severe or moderate to severe PTSD.

On Feb. 9, the FDA accepted the company’s new drug application for MDMA. The FDA granted the application priority review and has assigned a Prescription Drug User Fee Act target action date of Aug. 11. The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.