FDA approves compassionate use of Ecstasy


The U.S. Food and Drug Administration has granted Expanded Access to methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), enabling some patients to undergo treatment before the drug is formally authorized. MDMA, known by the street names Ecstasy and Molly, was developed and patented by E. Merck (now EMD Serono) a century ago. It was used as an empathogen in psychotherapy during the 1970s but was labelled as a Schedule I controlled substance (no medical use) in 1985.

Several phase II studies have been completed to date. A pooled analysis of phase II data (n=103) compared the change from baseline in the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) with MDMA 75-125 mg versus placebo/active control (MDA 25-40 mg) (Mithoefer et al. Psychopharmacology 2019;236:2735-2745). All subjects received inner-directed psychotherapy consisting of introspection sessions alternating with therapist-patient interactive sessions. Other psychoactive medications were discontinued during the studies but anxiolytics and sedative/hypnotics were permitted as needed. After two experimental sessions, MDMA/psychotherapy was associated with a significant reduction in CAPS-IV total score (-32.43 vs. -10.47 for controls). In the MDMA/psychotherapy group, 54.2% no longer met CAPS-IV criteria for PTSD versus 22.6% of controls. There was a non-significant improvement in depression scores. The most common adverse effects were anxiety, jaw clenching, headache, fatigue and lack of appetite. Serious adverse effects were suicidal ideation, suicidal behaviour and exacerbation of ventricular extrasystoles (one case each).

Two small phase III trials are now ongoing with results expected next year. Most of the MDMA studies to date have been funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization that promotes the medical and non-medical use of psychedelic drugs.

For a review of MDMA in psychiatry, see Sessa et al. Front Psychiatry 2019;10:138; free full text at www.ncbi.nlm.nih.gov/pmc/articles/PMC6435835/pdf/fpsyt-10-00138.pdf.

Recommend to a Colleague Go back to home page