FDA fast-tracks recreational drug MDMA for treatment of PTSD
pharmafile | August 30, 2017 | News story | Research and Development, Sales and Marketing | FDA, MDMA, PTSD, life sciences, pharma, pharmaceuticals
In another leap forward for the promising treatment, the FDA has announced that it has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD).
The US regulator has also come to an agreement with the Multidisciplinary Association for Psychedelic Studies (MAPS) on the design of two upcoming Phase 3 trials to test the drug through MDMA-assisted psychotherapy in severe forms of the condition, the first of which will begin enrolment in Spring 2018.
MDMA-assisted psychotherapy utilises three administrations of MDMA as an adjunct to psychotherapeutic techniques. Around 200-300 participants will be given either MDMA or placebo in addition to these techniques in three day-long sessions over 12 weeks, alongside 12 90-minute non-drug preparatory and integration sessions.
“Reaching agreement with FDA on the design of our Phase 3 programme and having the ability to work closely with the agency has been a major priority for our team,” explained Amy Emerson, Executive Director of the MAPS Public Benefit Corporation (MPBC). “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”
The Phase 2 trial in question showed that, after three sessions of MDMA-assisted psychotherapy, 61% of the 107 trial participants no longer qualified for PTSD.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in (advanced) trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS.
Matt Fellows
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