MDMA and the FDA Approval Process

Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times:

…those who received MDMA during therapy [in clinical trials] experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group.

That is very significant clinical evidence of the efficacy of MDMA.

Once relegated to the party scene, sponsors, scientists, and physicians are now testing MDMA for the treatment of certain disorders. As many know, MDMA is currently in clinical trials under an Investigational New Drug (“IND”) application that was filed with the U.S. Food & Drug Administration (“FDA”). The sponsor of this clinical trial is testing the efficacy of MDMA for the treatment of post-traumatic stress disorder. MDMA is in Phase 3 of the clinical trials, and approval as a new drug is no longer just a hypothetical. Once it is demonstrated that MDMA is efficacious and safe for those suffering from PTSD, the FDA should approve MDMA.

Read More Here…

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