MDMA tablets (Photo: Dominic Milton Trott)
The FDA recently denied a California-based drug company’s request to market MDMA, commonly known as ecstasy or molly, combined with talk therapy as a treatment for PTSD in Veterans.
Lykos Therapeutics, located in San Jose, had submitted the application, which received priority review due to strong support from Veterans seeking alternative PTSD treatments amidst persistently high suicide rates. However, the FDA concluded that more evidence was needed on the safety and efficacy of MDMA, requesting another advanced-stage clinical trial.
The decision has disappointed many, including Lykos Therapeutics’ CEO Amy Emerson, who expressed frustration over the years of work invested in this pioneering effort and the lack of new PTSD treatment options for millions of Americans. Completing the requested phase three clinical trial could take several years, further delaying potential access to this treatment. The FDA’s rejection came after its Psychopharmacologic Drugs Advisory Committee voted against MDMA as an effective treatment, citing concerns over the study’s design, data quality, and potential safety risks.
Despite the setback, Lykos plans to meet with the FDA to seek reconsideration and explore resubmission options. The company believes that many issues raised by the FDA could be addressed through existing data, post-approval requirements, or scientific literature. Earlier studies indicated promising results, with 86% of participants reporting reduced PTSD symptoms and 71% no longer meeting the diagnostic criteria for PTSD after receiving MDMA-assisted therapy.
The rejection has sent ripples through the psychedelic community, particularly among combat Veterans who have long advocated for psychedelic therapy. This advocacy has been closely associated with the Multidisciplinary Association for Psychedelic Studies, MAPS, a nonprofit organization supporting the medical and legal use of hallucinogenic drugs.
The decision also sparked political interest, with a bipartisan group of 60 House members, led by retired LtGen and U.S. Rep. Jack Bergman (R-MI), urging President Joe Biden to ensure a fair review of the therapy. They mentioned the FDA’s lack of innovation in PTSD treatments over the past 25 years, suggesting this may have contributed to rising Veteran suicide rates. The Institute for Clinical and Economic Review, an independent nonprofit, also raised questions earlier this year regarding the clinical trials’ design and results, adding to the controversy surrounding the FDA’s decision.
Author: Rikki Almanza
Rikki is a Web Content Coordinator for the American Legion, Department of California. With a deep-rooted connection to the military, a spouse who is a Navy veteran, a father who served in the Air Force for 25 years, and a grandfather who proudly served, Rikki is committed to using her skills and knowledge to provide valuable assistance and resources to servicemembers and veterans.
