FDA could approve MDMA and psilocybin in 2 years

To deal with a worsening mental health crisis in the U.S., the FDA is reportedly considering approving 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin within the next two years, according to a letter from a Substance Abuse and Mental Health Services Administration (SAMHSA) published by The Intercept. 

MDMA could be authorized as a treatment for post-traumatic stress disorder, while psilocybin could be authorized for treating depression. 

Both drugs have received Breakthrough Therapy Designation from the FDA. 

Clinical trial data suggest that MDMA and psilocybin, when paired with psychotherapy, can offer substantial therapeutic value to many patients. 

“SAMHSA agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” wrote Assistant Secretary for Menta…

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