The U.S. Food and Drug Administration has designated MDMA as a “breakthrough therapy” for the treatment of post-traumatic stress disorder, a significant milestone in the decades-long effort to turn the notorious illegal party drug — better known as ecstasy or “Molly” — into a prescription medication, Washington Post reports.
Paxil and Zoloft are currently the only medications approved for the treatment of PTSD. As the Post notes, both drugs have proven largely ineffective in treating the disorder in veterans.
“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,” John Krystal, chairman of psychiatry at Yale University and a director at the VA’s National Center for Psychiatry, told the Post. “That’s why there’s so much frustration and interest in finding something that works better.”
Remarkably, the FDA’s decision to designate MDMA as a “breakthrough therapy” marks the first time the rare designation has been granted to a psychiatric treatment, as it is reserved only for drugs that work alone or “in combination with one or more other drugs to treat a serious or life threatening disease or condition,” according to the FDA website. The drug must also demonstrate “substantial improvement over existing therapies.”
The effort to examine the medical applications of MDMA has been spearheaded by the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit organization founded in 1986 with the stated goal of developing “medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.” Its founder, Rick Doblin, is widely regarded as a pioneer among advocates of psychedelic drug use.
The new designation could open the door for MDMA as a prescribed treatment for U.S. military veterans. MAPS sponsored the Phase 2 clinical trials of MDMA-assisted psychotherapy, which began more than a decade ago, and many veterans of the wars in Iraq and Afghanistan enrolled in the trials. Almost all of them had seen combat, according to MAPS psychiatrist Dr. Michael Mithoefer, who spoke with Task & Purpose in December.
“There’s a lot of sleep disturbance, a lot of anxiety, and a lot of rage,” Mithoefer told Task & Purpose of the veterans who participated in the trials. “For some, the most troubling symptom was this rage that would come out towards their wives or their family members. It…