FDA set to evaluate use of ‘ecstasy’ for treating PTSD
Midomafetamine (MDMA)-assisted therapy may soon be approved by the U.S. Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD). The agency is set to deliberate on its recommendation June 4, bringing in a panel of outside experts to weigh in.
The application was submitted by Lykos Therapeutics, which is seeking the ability to investigate MDMA-assisted therapies and develop new drugs. MDMA currently has a Schedule 1 classification with the Drug Enforcement Administration (DEA), which designates a substance the agency believes to have no medicinal value.
However, Lykos contends MDA—more commonly known as “ecstasy”—could be a powerful treatment tool, and it backs its claim with two late-stage studies. The company earned a New Drug Application approval from the FDA in February to study MDA in combination with psychotherapy and other psychiatric interventions.
"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," Amy Emerson, CEO of Lykos Therapeutics said in a statement. "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 June 4 meeting will mark the first time in 25 years the FDA has examined a new potential treatment for PTSD. To date, no psychedelic-based therapy has been approved in the U.S.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.