A nonbinding Food and Drug Administration panel rejected a proposal to use MDMA, or ecstasy, to treat post-traumatic stress disorder.
Lykos Therapeutics and the Multidisciplinary Association for Psychedelic Studies tested the psychedelic drug, which can heighten feelings of intimacy and cause a euphoric sensation as opposed to causing the user to see trippy visuals, on PTSD patients.
Used in conjunction with therapy, MDMA could help patients overcome their trauma, the studies argued. The FDA experts disagreed.
On the question of whether ecstasy is effective in treating PTSD, the FDA’s Psychopharmacologic Drugs Advisory Committee voted no with a 9-2 margin. On a secondary question of whether the benefits of MDMA treatment outweighed the risks, the panel also voted no, 10-1.
The panel took umbrage with the lack of diversity in the study’s population. Only five Black and seven Asian participants were in stage three of the study, with most of the others White.
“I’m really concerned with this lack of real inclusion of BIPOC [Black, indigenous and other people of color] participants. … This seems to help people more if they’re White, and some of these effects disappear if they’re not. And the fact that this study has so many White participants is problematic because I don’t want something to roll out that only helps this one group,” patient representative Elizabeth Joniak-Grant said at the panel meeting Tuesday.
Another issue was that patients, due to the strong effects of the drug, could tell they were in the group being drugged and not the control group.
“But it seems like there are so many problems with the data. … When you’ve got unblinding and tons of confounds in the durability data … there’s not enough data on … people with severe PTSD. I think there’s a lot of questions still on how effective the treatment is and how durable it is,” Dr. Melissa Barone, psychologist with the Veterans Affairs Department, said.
The proponents of the MDMA treatment were displeased with the panel’s findings. While the FDA is not required to abide by the votes, the input could affect the agency’s final decision on the MDMA and therapy combined treatment in August.
“We are disappointed in today’s vote, given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention. We remain committed to working with the FDA to address outstanding questions so that we may find a path forward,” Lykos CEO Amy Emerson said in a release.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.