Use of MDMA (3,4-Methylenedioxymethamphetamine), most commonly known as the street drug Ecstasy, has been approved by the FDA for supervised use in therapy for treatment of posttraumatic stress disorder (PTSD).
The approval, known as Breakthrough Therapy Designation, was granted alongside approval of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD, in a program designed by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS has been working since 1986 to improve clinical and cultural understandings of the benefits of certain psychedelic drugs and marijuana.
The Breakthrough Therapy Designation is allotted by the FDA to treatment protocols that include single drugs or a combination aimed at treating life-threatening conditions or diseases. It may also be granted to protocols where preliminary research “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,” reports MAPS.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” Rick Doblin, Founder and Executive Director of MAPS, said in a statement. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”
Under the Phase 3 trials, 200-300 subjects will test the drug or a placebo in three-day-long treatments over a 12-week period combined with psychotherapy sessions.
“Reaching agreement with FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, said in a statement. “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.”
MAPS says after recently completing its Phase 2 trials with 107 participants, “61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.”
John Krystal, chairman of psychiatry at Yale University and a director at the VA’s National Center for PTSD, told the Washington Post that conventional drugs like Zoloft and Paxil are failing our returning soldiers in a big way. “If you’re a combat veteran with multiple tours of duty, the chance of a good response to these drugs is 1 in 3, maybe lower,” he said. “That’s why there’s so much frustration and interest in finding something that works better.”
The MAPS-approved protocol combines psychotherapy sessions with supervised administration of MDMA in a clinical setting of three single-dose treatments.
“Phase 2 clinical trials have shown that MDMA can reduce fear and defensiveness, enhance communication and introspection, and increase empathy and compassion,” MAPS says, noting that the combined neurological effects can enhance the therapeutic process for people suffering from PTSD.
According to MAPS, approximately seven percent of the U.S. population and 11-17 percent of U.S. military veterans experience PTSD will experience PTSD.
“As of June 2016, more than 868,000 veterans were receiving disability compensation for PTSD, with an estimated taxpayer cost of $17 billion per year,” MAPS explains. “PTSD is a stress-related condition associated with reduced cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, and increased risk of depression and suicide. In the general population, 27% of suicides are associated with PTSD.”
Drugs like MDMA, Doblin told the Post, “are a tool that can make people more compassionate, tolerant, more connected with other humans and the planet itself.”
Last April, Dr. Bronner’s, the popular natural soap and personal care company, pledged $5 million to MAPS’ research.
“There is tremendous suffering and pain that the responsible integration of MDMA for treatment-resistant PTSD will alleviate and heal,” David Bronner, Cosmic Engagement Officer (CEO) of Dr. Bronner’s, said in a statement. “To help inspire our allies to close the funding gap, my family has pledged $1 million a year for five years—$5 million total—by far our largest gift to an NGO partner to date. In part, we were inspired by the incredible example of Ashawna Hailey, former MAPS Board member, who gave MAPS $5 million when she died in 2011.”
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