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