The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD.
The decision was based on “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the FDA stated, according to The Associated Press.
MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamine, according to the National Institute on Drug Abuse.
FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS
Veteran organizations have long been advocating for approval of psychedelic-assisted therapies to treat mental health challenges.
The U.S. Food and Drug Administration announced Friday its rejection of MDMA as a treatment for PTSD. (iStock)
The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.
The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.
Lykos Therapeutics, the California company that filed the drug application, said it plans to meet with the FDA to appeal the decision, according to reports.
MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL
“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Amy Emerson, the Lykos CEO, said in a statement from the company.
“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”
Veteran organizations have long been…