Ecstasy, MDMA for PTSD: FDA approves expanded access, tests Visit

MDMA, an illegal psychedelic drug commonly known as ecstasy or molly, could be used to treat post-traumatic stress, researchers say. 

But access to the drug for testing has been difficult, even though the Food and Drug Administration in 2017 designated it as a “breakthrough therapy” for PTS treatment. 

Veterans experience PTS at a higher rate than the rest of the population. The Department of Veterans Affairs estimates 11-20 percent of veterans who served in the wars in Iraq and Afghanistan have PTS, compared to about 8 percent of non-veterans. 

Clinical tests of the drug are in their third phase, but people whose moderate or severe PTS  is resistant to other treatments could potentially benefit from early access to MDMA, according to the nonprofit research group, Multidisciplinary Association for Psychedelic Studies (MAPS). 

MAPS plans to allow early access to “potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked,” according to a MAPS news release

Phase 3 clinical trials are ongoing for the drug’s use in treating PTS, but the new approval from FDA will allow a select 50 patients at up to 10 sites in the U.S. earlier access to MDMA-assisted psychotherapy. Clinical trials are expected to be completed by 2021, meaning the FDA could approve the drug as soon as 2022. 

MDMA is a synthetic drug that acts as a stimulant and hallucinogen, producing an energizing effect, distortions in perception, increased self-awareness and empathy and “enhanced enjoyment from sensory experiences,” according to the National Institutes of Health (NIH). 

“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,” Dr. Michael Mithoefer, acting medical director for MAPS Public Benefit Corporation, said in a statement. 

MAPS hopes FDA will provide additional expanded access once it shows the drug helped its first 35 patients. 

Patients who participate in the treatment take a dose of the drug in a controlled clinical environment as part of a course of psychotherapy. They'll also be responsible for the costs of their treatment, unlike in the clinical trials.

After the drug is approved, patients will still not be able to take MDMA at home, and won’t fill prescriptions at a local pharmacy. The drug will only be available through a certified doctor in a supervised therapeutic setting, MAPS said. 

The expanded access or “compassionate use,” requires at least one therapist involved in treatment have a medical or clinical doctorate degree.

Selection of the 10 sites that will offer the treatment is expected to be announced in the coming months. More than 120 sites have applied, according to MAPS. Once the program starts, patients can apply to their preferred site. 

“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.”