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The U.S. health regulator has refused to approve a therapy based on the psychotropic drug MDMA for patients suffering from post-traumatic stress disorder, saying it could not be approved based on the data submitted, Lykos Therapeutics said Friday.
Commonly referred to as ecstasy or molly, MDMA has long been considered a potential treatment for mental disorders and has therapeutic applications beyond its illicit use.
The Food and Drug Administration’s decision not to approve the therapy was in line with the vote of the agency’s expert panel, which was reviewing an application for Lykos. At the panel’s meeting in June, FDA advisers had called attention to problems with how the clinical trial was conducted.
Lykos said the FDA has asked the company to conduct an additional late-stage trial to further study the drug’s safety and effectiveness.
The company plans to request a meeting with the FDA to reconsider the decision and discuss the agency’s recommendations for a new application for approval of the MDMA capsules.
