The U.S. Food and Drug Administration held a meeting to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder for the first time.
A panel of advisers to the U.S. Food and Drug Administration will meet on Tuesday to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder . The meeting by the agency's independent experts is the farthest that a drug based on MDMA, commonly known as ecstasy or molly, has ever reached in the FDA regulatory process for approval.
The treatment is a capsule form of MDMA made by the public-benefit corporation Lykos Therapeutics and is intended to be administered along with sessions of talk therapy by a licensed mental health provider. In clinical trials in over 190 patients, those who received doses of MDMA in addition to therapy showed a significant reduction in PTSD scores compared to placebo.
The FDA's staff proposed restrictions around its use and monitoring in their briefing documents on Friday. The FDA also flagged a rise in blood pressure and pulse in the trials and cases of liver toxicity. The approval could offer 'a new avenue of treatment, but itself is not going to make a big dent', due to costs and complexities associated with it, said Olson.
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