Ecstasy to treat PTSD by 2021? US FDA approves Ph III trial

By Dani Bancroft contact

- Last updated on GMT

iStock/portokalis
iStock/portokalis

Related tags: Pharmacology

Party drug MDMA has been claimed to be effective in helping treat Post-traumatic stress disorder (PTSD) patients, with the FDA approval for a Ph III trial to go ahead in the US.

Originally criminalised in the US in 1985, medical practitioners have returned to explore the clinical use of MDMA – the active pharmaceutical ingredient (API) in Ecstasy pills – in psychotherapy​.

Combining  the psychoactive stimulant with psychotherapy has shown significant promise​ in the treatment of ex US-military personnel suffering PTSD symptoms in proof-of-concept and Ph II trials.

The US FDA and Drugs Enforcement Agency (DEA) have granted permission for some manufacturers to produce small quantities​ of legal methylenedioxy-methylamfetamine (MDMA) for medical research.

The trials are being led and sponsored​ by Michael Mithoefer at the Multidisciplinary Association for Psychedelic Studies (MAPS) in South Carolina, US.

If the Phase III trial is successful, MAPS plans to file a new drug application (NDA) - which if approved by the FDA, aims to have controlled use of MDMA for PTSD by 2021​.

Related topics: Ingredients

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