Washington.- U.S. health officials on Friday declined to approve the psychedelic drug MDMA for use in treating post-traumatic stress disorder (PTSD), dealing a major setback to groups trying to win a decisive ruling in favor of using mind-altering substances to treat serious mental illnesses.
Drugmaker Lykos Therapeutics said it had been notified by the Food and Drug Administration that its drug “could not be approved based on the data submitted to date” and had requested an additional late-stage study. Such studies typically take several years and cost millions of dollars to conduct. The company says it plans to ask the FDA to reconsider its decision.
Lykos and other psychedelic makers had hoped that MDMA would be approved, paving the way for other hallucinogenic drugs to enter mainstream medical practice. Had the FDA granted the petition, MDMA — also known as ecstasy or molly — would have been the first illegal psychedelic substance to become a federally approved drug.
The FDA’s decision was expected to be unfavorable after a panel of government advisers voted overwhelmingly against using MDMA to treat PTSD in June. The negative vote followed a daylong meeting in which experts discussed data from the Lykos study, the research methods used and the drug’s potential risks, including heart problems, injuries and abuse.
The FDA said Friday that the MDMA approval application had “significant limitations” that “prevented the agency from concluding that the drug was safe and effective for its proposed use.” The agency added that it will continue to encourage “innovation in psychedelic treatments and other therapies to address these medical needs.”
Lykos said the concerns raised by the FDA in the so-called complete response letter reiterate concerns expressed during the June meeting.
“The fact that the FDA is calling for another study is deeply disappointing,” Lykos CEO Amy Emerson said in a statement Friday. “We grieve for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others suffering from PTSD who could now face more years without access to new treatment options.”
Essentially, Lykos is a spin-off of the Multidisciplinary Association for Psychedelic Studies (MAPS), the leading psychedelics advocacy group in the United States, which funded early MDMA research by raising millions of dollars from wealthy backers.
#rejects #psychedelic #MDMA #treating #PTSD
