FDA rejects ecstasy to treat PTSD

The U.S. Food and Drug Administration has declined the approval of the psychedelic medication 3,4-methylenedioxymethamphetamine, also known as ecstasy, for the treatment of patients with post-traumatic stress disorder.

Despite reporting positive findings in two late-stage clinical trials — which assigned patients with PTSD to receive ecstasy in combination with talk therapy — the medication’s manufacturer noted that the FDA requested more data from a phase III trial to better understand the safety and efficacy of the medication in these patients, according to a news story published in CNN. The agency cited concerns over missing safety information and bias in efficacy data from the previous trials as a rationale for requiring additional findings. The medication will continue to be categorized as a Schedule I drug, according to the Controlled Substances Act.

The manufacturer plans to meet with the FDA to determine a path forward prior to initiating the phase III trial. They said that if their treatment was approved, patients with PTSD may be able to better manage their psychological issues and reduce their rate of death.

Read more: CNN

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