Drug Scheduling and Breakthrough Therapy
MDMA (3,4 methylenedioxymethamphetamine), the molecule comprising the popular party drug dubbed “Ecstasy,” was cleared by the Food and Drug Administration in August 2017 as a breakthrough therapy for the treatment of Post-Traumatic Stress Disorder.
Breakthrough Therapy Designation was introduced in 2012 as part of the Food and Drug Administration Safety and Innovation Act. “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions,” according to the FDA. Thus, obtaining breakthrough therapy status means MDMA can be used in FDA-approved clinical trials for treating PTSD, the goal of which is the approval of MDMA for pharmaceutical use. A press release by the Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that ran the clinical trials, states, “MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct.”