Federal health officials have declined to approve the psychedelic drug MDMA as a therapy for PTSD.
Find Insider Deals for items perfect around the house and on the goFILE- A sign is displayed for the Food and Drug Administration offices in Silver Spring, Md., on Dec. 10, 2020. 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. The drugmaker said it plans to ask the agency to reconsider..
“The FDA request for another study is deeply disappointing," Lykos CEO Amy Emerson said Friday in a statement. “Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options.”
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.
The idea of using psychedelics to enhance psychotherapy is not new. A handful of therapists in California used MDMA during the 1970s and 1980s — when it was still legal — to facilitate couples therapy sessions. MAPS was founded in 1986 to oppose a federal decision placing MDMA in the same ultra-restrictive drug category as heroin, LSD and other illegal psychedelics.
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