Federal health officials have declined to approve the psychedelic drug MDMA as a therapy for PTSD. Drugmaker Lykos Therapeutics announced the FDA's decision on Friday.
Military veterans have spent years lobbying for the use of psychedelic drugs to treat PTSD and other hard-to-treat mental health conditions. But a sharply critical review of the club drug MDMA has put the drug’s approval in doubt. Drugmaker Lykos Therapeutics said the FDA notified the company that the drug “could not be approved based on data submitted to date,” and requested an additional late-stage study. Such studies generally takes several years and millions of dollars to conduct.
Lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the initial studies of MDMA by raising millions of dollars from wealthy backers. Antidepressants are now the only FDA-approved drugs for post-traumatic stress disorder, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans., who say the lack of treatments options for PTSD has contributed to higher rates of suicide among military personnel. Last month, veterans supporting psychedelic therapy lobbied on Capitol Hill in support of the drug.
In recent months, separate allegations of misconduct have emerged, including that some researchers involved in the studies coached patients to suppress negative results or inflate positive ones.that are expected to be reviewed by the FDA in coming years as part of a resurgence of interesting into their therapeutic potential.
Medical Research Anxiety Mental Health Health Business Medication F Post-Traumatic Stress Disorder Politics W Psychotherapy
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