FDA Approves Trials for MDMA as Treatment for PTSD
December 14, 2016   

As many as 24.5% of Iraq and Afghanistan veterans may suffer with posttraumatic stress disorder (PTSD), a disorder characterized by re-experiencing, avoidance, arousal, and changes to mood and cognition. Available pharmacological treatments approved for treating PTSD (sertraline and paroxetine) have very limited efficacy and psychotherapeutic options such as prolonged exposure (PE) therapy, although possibly efficacious, are intolerable for many patients. Given that an estimated 22 veterans (many with PTSD) commit suicide every single day, finding novel therapeutic options that are both tolerable and effective is key. Due to the urgency of this need, the FDA has recently given the green light for large phase 3 studies testing 3,4-methylenedioxymethamphetamine (MDMA) in patients with PTSD. This approval is based on several small studies that have shown a significant benefit of MDMA in reducing symptoms of PTSD as well as improving depression, anxiety, cognition, prosocial behaviors, and quality of life in patients with PTSD. In fact, results from a 2016 meta-analysis indicate that MDMA combined with psychotherapy is as effective as prolonged exposure therapy with much greater tolerability and lower dropout rates for patients (Amoroso and Workman, 2016). Large-scale studies of MDMA have been impeded in the past due to the fact that MDMA, widely known as the "party drug" ecstasy, is listed as a Schedule 1 substance by the United States Drug Enforcement Agency. With the new approval for MDMA to be more rigorously studied as part of a treatment for PTSD, many patients and clinicians are hopeful that relief from symptoms of PTSD may be near at hand.

Learn more about the FDA's decision here.

Meta-analysis: Amoroso T, Workman M. J Psychopharmacology 2016;30(7):595-600.