The FDA Just Expanded Access to MDMA as a Therapy for PTSD
The U.S. Food and Drug Administration just made it a lot easier for patients with hard-to-treat post-traumatic stress disorder to use MDMA, a popular rave drug, to treat their condition. Under an FDA program known as Expanded Access, 10 sites across the nation can apply for approval to administer the drug under a doctor’s supervision. Just 50 patients will be enrolled, but it could open the door to wider availability of MDMA and give real-world evidence that the drug works as effectively as studies suggest.
The moment MDMA was made illegal in 1985, activists and psychiatrists who saw value in this psychedelic amphetamine immediately began work to undo the ban. One organization formed in this wake was MAPS, the Multidisciplinary Association for Psychedelic Studies, which has funneled millions into clinical trials for MDMA and is expected to make it available for prescription by 2021. Now 34 years after MAPS formed, those aspirations are being realized, at least in part.
On Friday, MAPS announced the FDA had given it permission to enroll PTSD patients who have tried unsuccessfully to treat their condition in MDMA psychotherapy under Expanded Access, sometimes known as “compassionate use.”
It allows patients with serious or life-threatening conditions who can’t participate in clinical trials to try experimental drugs that haven’t yet been FDA-approved. In 2017, the FDA labeled MAPS’s MDMA program a “breakthrough” therapy, granting it a priority review process based on promising results.
MDMA, sometimes called Molly or ecstasy, is in a class of drugs called empathogens, which boost social connectedness, self-love, empathy and euphoria. The drug floods the brain with feel-good neurotransmitters like serotonin and dopamine, while also temporarily extinguishing the brain’s ability to process fear.
For patients with complex, treatment-resistant PTSD, this brief reprieve from the plague of traumatic emotions can allow them to effectively process difficult memories. (To be truly effective, however, the drug typically needs to be combined with therapy. Taking MDMA at Coachella with your buddies probably won’t be as therapeutic as doing the drug with a trained professional.)
“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” Michael Mithoefer, acting medical director for MAPS Public Benefit Corporation, said in a press release. “Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche.”
MAPS sees great potential in MDMA-assisted psychotherapy and over the years has undertaken a $26.9 million plan to turn MDMA into a prescription drug. The nonprofit is currently in the final phase of research before the drug is made available to the public, pending the FDA’s blessing. More people taking the drug under clinical supervision could bolster evidence that MDMA works.
After the first 35 patients enroll in the Expanded Access program, MAPS plans to submit its patient data to the FDA so the agency can decide whether or not to broaden the program. One caveat: insurance won’t cover treatment, so patients must pocket expenses themselves. According to DoubleBlind Magazine, the therapeutic treatment may average around $15,000, although MAPS is working with health insurance companies to change that.
The Expanded Access announcement comes the same day as research from the Medical University of South Carolina demonstrated even more efficacy for MDMA as a treatment for PTSD. A review of six clinical trials in four countries found that “MDMA-assisted psychotherapy was significantly more effective at treating patients with persistent PTSD than unassisted psychotherapy,” according to findings presented at the annual meeting of The American College of Neuropsychopharmacology.
Between 6-8 percent of people suffer from PTSD, but for a third of these folks, conventional treatment does not work. Surviving traumatic experiences, such as child abuse or a warzone, can create neurobiological changes in the brain that provoke uncontrollable nightmares and flashbacks, especially after triggers reminiscent of the traumatic event. There are currently only a handful of FDA-approved medications for PTSD, and all have about the same efficacy. New treatments for PTSD are desperately needed, whether it’s MDMA or something else.
“We commend FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” MAPS founder and executive director Rick Doblin said in a statement. “We are delighted to begin generating real-world evidence about this potential new treatment.”
Troy Farah is an independent journalist from Southwest California. His reporting on drug policy and science has appeared in WIRED, The Guardian, Undark, Discover Magazine, VICE and more. He co-hosts the drug policy podcast Narcotica. Follow him on Twitter.