The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported.
The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy—or 3,4-Methylenedioxymethamphetamine (MDMA)—saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available.
Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients.
The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana.
“The medicine allows them to look at things from a different place and reclassify them,” said Ann Mithoefer, a psychiatric nurse who conduced some of the early trials with her husband, Michael C. Mithoefer, a psychiatrist. “Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”
The Mithoefers and their colleagues through MAPS have applied for a speedy approval process through the FDA, allowed for therapies that could be “breakthroughs.” If everything goes as they plan, MDMA could be available as a prescription medication by 2021.
Previous research found that MDMA spurs the release of hormones and neurotransmitters in the brain, such as norepinephrine, dopamine, and serotonin, which increase heart rate and energy and produce a sense of euphoria, emotional closeness, and trust. In the 1970s, researchers believed it to be a promising drug to treat psychiatric disorders. However, as recreational use became more popular and instances of abuse rose, the Drug Enforcement Administration listed MDMA as a Schedule I drug in 1985, making it illegal and labeling it as having no accepted medical uses.