Nov. 30, 2016 -- Large-scale Phase 3 clinical trials of the illegal party drug Ecstasy as a treatment for post-traumatic stress disorder (PTSD) were approved Tuesday by the U.S. Food and Drug Administration.
Some small studies have yielded promising results. If the new trials are successful, Ecstasy (MDMA) could be approved as a prescription drug for PTSD, The New York Times reported.
An FDA spokeswoman declined to comment on the matter, citing rules that forbid providing information about drugs under development.
"I'm cautious but hopeful," Dr. Charles Marmar, a leading PTSD researcher and head of psychiatry at New York University's Langone School of Medicine, told The Times.
"If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don't help 30 to 40 percent of people. So we need more options," he said.
However, Marmar said he's concerned about the potential for abuse if MDMA is approved to treat PTSD.
"It's a feel-good drug, and we know people are prone to abuse it," he said. "Prolonged use can lead to serious damage to the brain."
The Phase 3 research, which will include at least 230 patients with PTSD, will be funded by the non-profit Multidisciplinary Association for Psychedelic Studies, which previously sponsored six Phase 2 studies that treated a total of 130 PTSD patients with MDMA, The Times reported.
Two of those studies included combat veterans, sexual assault victims, and police and firefighters who had PTSD for an average of 17 years and had not responded to traditional prescription drugs or psychotherapy.
In one study, patients had an average 56 percent decrease in severity of PTSD symptoms after receiving three doses of MDMA administered under a psychiatrist's guidance. By the end of the study, two-thirds of patients no longer met the criteria for having PTSD. Improvements lasted more than a year after treatment.
"We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all," study author and psychiatrist Dr. Michael Mithoefer told The Times.
"We think (MDMA) works as a catalyst that speeds the natural healing process," he explained.
Mithoefer and his colleagues have applied for what's known as breakthrough therapy status with the Food and Drug Administration, which would speed the approval process for MDMA. If approved, the drug could be legally available by 2021, The Times reported.
But even if strict controls are put in place, approval of MDMA as a prescription drug could lead to increased illegal recreational use, some experts warn.
"It sends the message that this drug will help you solve your problems, when often it just creates problems," Andrew Parrott, a psychologist at Swansea University in the U.K. who has studied the brains of chronic Ecstasy users, told The Times.
"This is a messy drug we know can do damage," he said.
Approving MDMA as a prescription drug could inadvertently lead to an abuse epidemic similar to the current opioid crisis, Parrott told The Times.