The FDA just gave the drug "breakthrough therapy" status. Here's what that could mean for future PTSD treatment.
If you've ever heard of the party drug ecstasy, you may associate it with raves, Phish concerts, or dance clubs playing bangers till dawn. But the FDA has now granted the psychoactive compound in ecstasy, MDMA, "breakthrough therapy" status. It's now in the final stages of being tested as a treatment for post-traumatic stress disorder (PTSD), as stated in a press release from the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization.
Not only does that particular classification mean that MDMA has been effectively treating patients in previous trials, but also that it's so efficacious that its final phases of testing are expedited. Pretty serious for a party drug, right?
"By granting [MDMA] breakthrough therapy designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD," says Amy Emerson, the executive director and director of clinical research at MAPS. "We'll have a meeting with the FDA by the end of this year—2017—to understand more clearly how we will work closely to ensure the project proceeds and where any possible efficiencies in the timeline can be gained."
PTSD is a serious problem. "Approximately 7 percent of the U.S. population—and 11 to 17 percent of U.S. military veterans—will have PTSD sometime in their life," says Emerson. And the past research on using MDMA-assisted psychotherapy on patients with PTSD has been jaw-dropping: Looking at 107 people with chronic PTSD (averaging 17.8 years of suffering per individual), 61 percent no longer qualified as having PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68 percent no longer had PTSD, according to MAPS. But since the sample size was so small—and across just six studies, says Emerson—Phase 3 testing with the FDA is needed to prove MDMA's efficacy on a larger scale.
It's important to note that the MDMA these patients are using in their psychotherapy sessions isn't the same as the stuff you'd get at a party. "The MDMA used for the studies is 99.99% pure and made so it follows all regulatory requirements for a drug," says Emerson. "It's also administered under clinical supervision." "Molly," on the other hand, is sold illegally and may contain little to no MDMA, along with other harmful substances.
And unlike taking a street drug, MDMA-assisted psychotherapy is administered in three single-dose psychotherapy sessions spaced three to five weeks apart. It also includes social support, along with mindfulness and breathing exercises. So while this isn't the okay to take a party drug, it's definitely promising research for those suffering from PTSD.