The FDA in the USA has announced a “breakthrough therapy” for post traumatic stress disorder (PTSD). The regulator has determined the drug MDMA, commonly known as ecstasy, can be used for the treatment of PTSD. By giving it the breakthrough therapy designation, the FDA agrees that the treatment “may have a meaningful advantage and greater compliance over available medications for PTSD”. The announcement was made by the not-for-profit organisation Multidisciplinary Association for Psychedelic studies (MAPS).
Trials using MDMA-assisted psychotherapy for patients with severe PTSD can now move forward to Phase III. This is a very important step forward in the development of PTSD treatment, and Rick Doblin, Founder and Executive Director of MAPS stated “For the first time ever psychedelic-assisted psychotherapy will be evaluated in Phase III trials for possible prescription use, with MDMA assisted therapy leading the way. Now that we have agreement with the FDA, we are ready to start negotiations with the European Medicines Agency”.
The trials are set to take place in the USA, Canada and Israel and will recruit 200-300 participants, aged 18 years and older. The Phase III trials will test the efficacy and safety of MDMAassisted psychotherapy in patients with PTSD. Patients will be randomised to receive MDMA or placebo in combination with psychotherapy, in 3 sessions lasting for a day each time, over a twelve- week period. Patients will also attend 12 preparatory sessions, lasting 90 minutes each.