Washington — US health authorities declined on Friday to approve the psychedelic drug MDMA for use as a therapy for post-traumatic stress disorder (PTSD).a major setback for groups trying to obtain a decisive ruling in favor of using mind-altering substances in the treatment of serious mental illnesses.
Pharmaceutical company Lykos Therapeutics said the Federal Food and Drug Administration (FDA, in English) had notified him that his drug “could not be approved based on the data presented 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 that petition, MDMA would have —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 group of government advisers voted overwhelmingly against the use of MDMA for the treatment of PTSD in June.The negative vote came after a daylong meeting in which experts reviewed 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 application for approval of MDMA had “significant limitations” that “theand 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 asking 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 who suffer from PTSD and who could now face more years without access to new treatment options.”.
In essence, Lykos is a company derived from the Multidisciplinary Association for Psychedelic Studies (MAPS)the leading psychedelics advocacy group in the United States, which funded early MDMA studies by raising millions of dollars from wealthy backers.