MAPS Bulletin Spring 2018: Vol. 28, No. 1
The Multidisciplinary Association for Psychedelic Studies (MAPS) is poised on the brink of initiating the most important and consequential research in our 32-year history: Phase 3 studies into MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) for the purpose of obtaining approval by the U.S. Food and Drug Administration (FDA) for prescription use. MAPS has resolved all regulatory issues and has obtained an FDA Agreement Letter, successfully concluding our Special Protocol Assessment process in which we negotiated all aspects of our Phase 3 protocol design and associated data that are required prior to prescription approval. The Agreement Letter is a written commitment by the FDA to approve MDMA-assisted psychotherapy for PTSD if our Phase 3 protocol design generates statistically significant results, and no new safety issues arise during Phase 3.
MAPS has also obtained Breakthrough Therapy Designation from the FDA for MDMA-assisted psychotherapy for PTSD, indicating that the agency considers MDMA-assisted psychotherapy for PTSD among the most promising treatments being developed. The FDA rejects about two-thirds of requests by pharmaceutical companies for Breakthrough Therapy Designation. MAPS has also raised almost all of the funds we’re trying to raise for Phase 3 for the FDA trials, with $26.2 million of $26.7 million already donated or pledged in multi-year commitments.
Currently, MAPS is in the final stages of training about 80 therapists to work in 40 male/female co-therapist teams at 15 or 16 Phase 3 sites in the US, Israel, and Canada. To prepare for the Phase 3 trials, each new co-therapy team is working with one PTSD patient in an open-label protocol in which all participants receive MDMA (not placebo), with supervision and feedback provided by MAPS’ therapist training team. Due to MDMA’s status as a controlled substance, we can only provide therapists with experience administering MDMA-assisted psychotherapy to PTSD patients inside a protocol that has been approved by the FDA and the Drug Enforcement Administration (DEA). We anticipate completing the training of all of our Phase 3 therapists by Fall 2018, with Phase 3 starting at most of our sites this August and taking roughly two years to complete.
MAPS is also in the midst of negotiations with the European Medicines Agency (EMA). We have just learned that the EMA will schedule an in-person meeting in London between EMA officials and MAPS and MAPS Public Benefit Corporation (MPBC) staff in early June. The purpose of this meeting will be to discuss what data EMA will require for prescription approval in the European Union in addition to the data we will be gathering for the FDA. We anticipate coming to agreement with EMA before the end of this year. If we can raise the roughly $5 million we’re currently estimating we’ll need for new data for EMA, we can begin Phase 3 in Europe in the summer of 2019—and I think we can. We can then complete Phase 3 trials in Europe in 12 to 16 months, depending on how many subjects EMA will require to be treated in Europe and how many Phase 3 sites we establish.
MAPS is thinking globally, and working to start small Phase 2 MDMA-assisted psychotherapy for PTSD studies in Brazil, Colombia, Australia, and other countries where regulations may permit approval for prescription use based on MAPS’ US and European Phase 3 data, with locally trained therapists. MAPS is even involved in preliminary explorations regarding initiating this research in China. Russia, unfortunately, is still completely blocking research with MDMA and other psychedelics, but perhaps one day Russian politicians will realize that they are falling behind in the race to obtain prescription approval for psychedelic-assisted psychotherapy.
MAPS’ 18-year effort, which started in 2000, to end the 50-year federal monopoly on the supply of DEA-licensed cannabis legal for use in FDA-regulated research, is also approaching what feels likely to be a successful conclusion. Ever since his appointment by President Trump, Attorney General Jeff Sessions has blocked the DEA from issuing licenses to the roughly 26 applicants who have submitted the necessary paperwork. We have been waiting since August 2016, when the DEA under President Obama filed a rule in the Federal Register indicating that it would approve new licenses to grow cannabis for federally-regulated research. Congressional pressure on Sessions is now building in both the Senate and the House of Representatives, with Senators Hatch and Harris sending a letter to Sessions demanding that all license applications be either approved or rejected by August 11, 2018. In his Senate testimony in October 2017 and again in April 2018, even Sessions has indicated that he supports ending the federal monopoly. The wait for actions rather than just words may soon be ending, though of course nothing is certain.
Once the federal marijuana monopoly does end, MAPS will have access to a supply of cannabis that could ultimately be sold as a prescription medicine. First, we’ll need to complete our study of four different kinds of cannabis (THC, CBD, combined THC and CBD, and placebo) in 76 veterans with chronic, treatment-resistant PTSD, now taking place in Phoenix, Arizona, with Site Principal Investigator Dr. Sue Sisley. Then we can analyze the data and determine if it makes sense to try conducting additional drug-development research with cannabis for PTSD and, if so, how MAPS could raise the roughly $25 million we’d need for that research effort.
Our culture is going through a transformative process that bodes well for the mainstreaming of the medical uses of psychedelics and marijuana. One prominent example of this is journalist Michael Pollan’s brand new book on psychedelics, How to Change Your Mind, which as of today has reached #1 on Amazon’s bestseller list. With the continued support and donations of those who want to see us complete our work, our goal of obtaining approval for the prescription use of MDMA and marijuana is becoming much more than a dream.
Rick Doblin, Ph.D.
MAPS Founder & Executive Director