Reset: In 6 Years, MDMA Could Be A Legal Pharmaceutical For Therapy

April Short of Reset reports on MAPS’ research developing MDMA-assisted psychotherapy into an FDA-approved prescription treatment for PTSD by 2021. The article details MAPS’ approach to conducting MDMA research and features an interview with Brad Burge of MAPS about how the future sale of MDMA by the newly formed MAPS Public Benefit Corporation will help sustain psychedelic therapy research into the future. “There are possible projections of making anywhere from $10 to 30 million within the first five years of sales of MDMA,” Burge said. “That way MDMA is opening the door, and keeping the door open, for the continuation of psychedelic research.”

Originally appearing here.

MDMA, which in the world of recreational psychedelics often goes by the nicknames “ecstasy” and “Molly,” could realistically be an approved pharmaceutical drug within seven years. Its approval would be the results of a labor of love on the part of Rick Doblin who founded the non-profit, donor-funded research and educational organization Multidisciplinary Association for Psychedelic Studies (MAPS) more than 20 years ago.

In the ’70s and ’80s, Doblin was among a many psychiatrists, marriage counselors and therapists using the not-yet-illegal substance in clinical settings to treat patients. In a panicked reaction to its increasing popularity in the party/rave scene, the government criminalized MDMA in 1985. Dobin originally founded MAPS as a response to MDMA’s prohibition. The organization has been working to see it legalized ever since, funding research into the healing potential of MDMA-assisted psychotherapy on psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas.

Doblin told me in a 2013 interview that he had no idea how long it would take, how much it would cost, or how hard it would be to legitimize psychedelics like MDMA.

“I’m glad I wasn’t quite clear on all of that,” he said. “One thing I’ve learned now that I’m almost 60 is that time speeds up when you get older. In MAPS I see, all the time now, seeds that were planted 20, 30 years ago that are now coming into play.”

Since its founding, MAPS has grown to be one of the top research and education organizations sponsoring clinical research on psychedelics around the world. Their government-approved, placebo-controlled human trials look at LSD, psilocybin, Ibogaine and ayahuasca (and they’ve been working for over a decade to get approval to study marijuana). Many of their studies have been groundbreaking — like one completed last year showing LSD’s promise for reducing anxiety about death. But their MDMA research in particular has turned over some overwhelming results.

Their phase I studies assessing the efficacy of MDMA-assisted psychotherapy for PTSD symptoms did so well that they’re currently funding two phase II trials.

One phase I study, completed in South Carolina, looked at people with severe, treatment-resistant PTSD. For the study, patients took various specified doses of MDMA in a clinical setting and worked with a trained therapist for eight or more hours, on several occasions. The study was placebo controlled, meaning participants did not know how much, if any, MDMA they were receiving.

Following the treatments, 83% of study participants no longer qualified as having PTSD. All other phase I studies also returned statistically significant, overwhelmingly positive results, which is why MAPS research has qualified to enter into phase II trials. The organization is already preparing for phase III trials, which will require hundreds of therapists to look at thousands of participants. Phase III is the final phase of study before a drug is approved in the U.S.

Brad Burge, communications director for MAPS, said the organization predicts that the FDA could approve MDMA as a legal medication by the end of 2021. Once it’s approved, only psychiatrists will be able to legally acquire the MDMA, which they will then give to the appropriate patients during therapy sessions. The FDA will only be approving the pharmaceutical status of MDMA, not the therapy portion of the treatment, but Burge says it will come with a note saying that it’s intended for use alongside a trained therapist.

Methadone, a synthetic opiod used to reduce symptoms of withdrawal from substances like heroin, is one of the only existing examples of a pharmaceutical with a parallel approval in place; it can only be administered in a medical setting, not prescribed by a doctor.

Public Benefit Corp

In anticipation of MDMA’s debut as a legal medicine, MAPS has created a wholly-owned, for-profit subsidiary called MAPS Public Benefit Corporation (MPBC). MPBC will allow the organization to donate all of its profits from selling MDMA back to the nonprofit, 501c3 MAPS.

Burge said that because of its nonprofit status, charging a normal market rate for MDMA would mean taking in so much money it would risk the organization’s nonprofit status. While the MAPS team discussed the possibility of keeping the cost of MDMA low enough to barely cover the cost of production, they decided that creating the subsidiary would benefit more psychedelic research in the long run.

Since psychotherapy is already expansive and covered by insurance, and most insurance would cover the higher priced medicine, the organization decided charging the higher market rate wouldn’t limit access to the treatment. What it would do is give MAPS a sustainable way to support its many psychedelic research projects without relying so heavily on donors.

“By increasing how much we’re charging for the MDMA, we can actually gain a considerable profit from the sale of MDMA without negatively impacting the actual costs of the therapy for people too much,” Burge said. “So that income can then be used to go back into MAPS research, which will then reduce our reliance on donations.”

Research expenses incurred by MPBC will be used to reduce taxes on income received by MPBC from legal sales of MDMA. The subsidiary will donate 100% of its profits to the MAPS 501c3.
“There are possible projections of making anywhere from $10 to 30 million within the first five years of sales of MDMA,” Burge said. “That way MDMA is opening the door, and keeping the door open, for continuation of psychedelic research.”