US Food and Drug Administration advisers have voted against a therapy based on the mind-altering drug MDMA, known as “ecstasy”, for patients with post-traumatic stress disorder, saying the benefits did not outweigh the risk.
The panel voted 10-to-one against the treatment, with nine of them saying the available data did not show its effectiveness in this patient group.
Reuters reports that much of the panel’s discussion centred on how the trials were conducted, as well as issues pertaining to their design and data collection.
The agency is not required to follow the panel’s advice, but usually does so and is expected to make its final decision by August.
MDMA has long been seen by advocates as a potential treatment for mental health disorders and to have therapeutic applications beyond its illicit use.
The treatment, a capsule form of MDMA made by public-benefit corporation Lykos Therapeutics, is intended to be administered along with sessions of talk therapy by a registered mental health provider.
Other non-profit medical groups, including the Institute for Clinical and Economic Review (ICER) and American Psychological Association, had earlier said there was “insufficient” evidence to show the benefits of the treatment.
Reviewers had also raised concerns that patients in the trials were aware of whether they were given MDMA or a placebo due to its psychedelic effects, preventing an objective view of how well the drug worked, while the FDA said there was a “striking lack” of documentation of abuse-related adverse events, which could limit the agency’s ability to explain the effects of MDMA or determine its abuse liability.
More than 190 patients who received doses of MDMA in addition to therapy showed a significant reduction in PTSD scores compared with placebo, and Lykos CEO Amy Emerson said they were disappointed in the vote, “given the urgent unmet need in PTSD”.
Reuters article – US FDA panel votes against first MDMA-based PTSD treatment (Open access)
See more from MedicalBrief archives:
Ecstasy approval for PTSD likely after large trial
Study finds that ecstasy could help with PTSD treatment
MDMA (ecstasy) treatment for alcoholism could reduce relapse