Photo: The Associated Press
Federal health regulators have decided not to approve the psychedelic drug MDMA as a treatment for PTSD, marking a significant setback for advocates hoping to see mind-altering substances used to treat serious mental health conditions.
Lykos Therapeutics, the company behind the drug, announced that the FDA informed them that the current data is insufficient for approval and requested an additional late-stage study. Such studies typically take several years and require substantial financial investment. Despite the setback, Lykos plans to appeal the decision.
MDMA, also known as ecstasy or molly, was anticipated to be the first illegal psychedelic to gain federal approval as a medical treatment. This approval was hoped to open the door for other hallucinogenic drugs to be used in the medical field. However, the FDA's decision followed a June advisory panel's overwhelming vote against using MDMA for PTSD. During an all-day meeting, experts reviewed Lykos' study data, research methods, and potential risks, including heart issues, injuries, and the potential for abuse.
On Friday, the FDA cited "significant limitations" in the MDMA application that prevented the agency from concluding the drug's safety and efficacy. They expressed continued support for innovative psychedelic treatments to address medical needs.
Lykos CEO Amy Emerson expressed disappointment, noting the delay in potential new treatment options for PTSD sufferers, including military veterans, first responders, and abuse victims.
Lykos is closely linked to the Multidisciplinary Association for Psychedelic Studies (MAPS), a leading advocacy group for psychedelic research. MAPS funded the initial MDMA studies, which showed promising results when combined with talk therapy, easing PTSD symptoms significantly.
Currently, antidepressants are the only FDA-approved drugs for PTSD, a condition linked to depression
