FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

A institution seeking to dainty post-traumatic accent upset with a operation of MDMA and speech therapy conscionable suffered a large setback from the U.S. Food and Drug Administration.

Lykos Therapeutics, the steadfast aiming for FDA approval, said connected Friday that it received a rejection letter from the agency, which called for much probe into the imaginable treatment’s information and efficacy. Lykos said successful effect that it wants the FDA to reconsider the decision, adding that it volition petition a gathering to “further sermon the agency’s recommendations for a resubmission.” MDMA, besides known arsenic molly and ecstasy, is simply a lab-made cause developed much than a period agone by a chemist astatine the German pharmaceutical elephantine Merck.

The determination follows an earlier ballot from FDA advisors, who rejected the MDMA-assisted therapy successful June. The sheet questioned the treatment’s semipermanent efficacy and safety, the prime of Lykos’ data, and the conduct of therapists who participated successful earlier Lykos studies. While the FDA had the enactment to enactment against its panel’s feedback, the bureau reportedly reached a akin conclusion.

According to Lykos CEO Amy Emerson, conducting a 3rd signifier 3 proceedings would acceptable the steadfast backmost respective years. Calling the FDA’s missive “deeply disappointing,” Emerson argued successful a connection that the agency’s requests “can beryllium addressed with existing data, post-approval requirements oregon done notation to the technological literature.”

Lykos did not people the rejection letter, and the FDA did not instantly respond to Gizmodo’s petition for much information. However, a spokesperson for the bureau told NPR connected Friday, “there are important limitations to the information contained successful the exertion that forestall the bureau from concluding that this cause is harmless and effectual for the projected indication.”

The spokesperson added that the bureau “will proceed to promote probe and cause improvement that volition further innovation for psychedelic treatments and different therapies.”