An FDA panel voted against approving using MDMA in combination with talk therapy to treat PTSD. File Photo by Robin Van Lonkhuijsen/EPA-EFE
The popular underground drug midomafetamine, also called MDMA and “ecstasy,” failed to win an advisory panel’s support as a treatment for post-traumatic stress disorder Tuesday.
The independent federal advisory panel voted 9-2 against authorizing the drug’s use for treating PTSD after listening to presentations by the Food and Drug Administration, Lykos Therapeutics and the public. Advertisement
Although “encouraged” by the experimental treatment’s results so far, one panel member said more evidence is needed to show it is relatively safe and viable method of treating PTSD.
“Premature introduction of a treatment can actually stifle development and stifle innovation,” committee member Dr. Paul Holtzheimer said during the panel discussion.
Holtzheimer is the deputy director of research for the National Center for PTSD.
Lykos Therapeutics was sponsoring the defeated treatment plan’s consideration for federal regulatory approval.
The nine detractors said MDMA is ineffective at treating PTSD, while the other two committee members said it is an effective treatment.
Those opposed to its approval said there’s not enough data showing the drug effectively treats PTSD.
A larger majority also said the proposed treatment’s potential risks outweigh its potential benefits while only one disagreed in a 10-1 vote on its efficacy. Advertisement
The FDA isn’t bound by the panel’s decision, but it creates a significant hurdle to approving MDMA’s use as part of an accepted PTSD treatment.
Lykos Therapeutics’ recommends combining MDMA as a medicinal treatment in combination with talk therapy to assist military veterans and others struggling with PTSD.
