MDMA Inches Closer to Prescription Status after New FDA Approval

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The FDA has authorized Phase 3 trials for MDMA as a treatment for PTSD, the final step before it can be approved as a prescription drug.

Last year, Phase 2 trials focused on treating a pool of 130 patients, including combat veterans, sexual assault victims, and police and firefighters with PTSD.

As the results from that trial were promising, with patients reporting a 56 percent decrease of severity of symptoms, researchers are going ahead with the next phase.

“I’m cautious but hopeful,” expressed Dr. Charles R. Marmar, head of psychiatry at New York University’s Langone School of Medicine, to the New York 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.”

It’s important to note that taking MDMA is not the only requirement for the trials. Patients who participated in the previous trials had to undergo 12 weeks of psychotherapy, which incorporated three eight-hour sessions of MDMA usage. As described by the New York Times, “during the sessions, they lay on a futon amid candles and fresh flowers, listening to soothing music”.

Lead by Dr. Michael C. Mithoefer and his wife, Ann Mithoefer, for the sessions they sat with the patients helping them work through their memories that cause PTSD.

“The medicine allows them to look at things from a different place and reclassify them,” said Ms. Mithoefer. “Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”


On the other side of the spectrum, Andrew Parrott, a psychologist at Swansea University in Wales who has studied the effects of ecstasy on the brain, is still skeptical of the trials: “It sends the message that this drug will help you solve your problems, when often it just creates problems. This is a messy drug we know can do damage.”

Phase 3 trials are set to begin in 2017 with at least 230 patients partaking in the study. If the trials are successful and earn the endorsement from the FDA, MDMA could be approved as a prescription drug by 2021.

h/t nytimes, mixmag