The Phase 3 trial is last step on the way to approval as a prescription drug
The Food and Drug Administration (FDA) has approved the use of MDMA in large-scale trials as a treatment for post-traumatic stress disorder (PTSD).
Small scale studies have previously used the drug, also known as the party-drug ecstasy, to alleviate some of the symptoms of PTSD. As reported by the New York Times, the FDA green lit a Phase 3 clinical trial, which is significant as it marks the final stage of testing before it can be submitted for approval as a prescription drug.
Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine and a leading PTSD researcher, told the Times that he was “cautious but hopeful.”
Study participants have previously reported significant improvements in their condition following a course of MDMA therapy, and researchers have been optimistic about the future of the drug as a form of treatment. “If they can keep getting good results, it will be of great use,” Marmar said. However, he also voiced some caution, which was echoed by other reactions to the FDA’s approval. “It’s a feel-good drug, and we know people are prone to abuse it,” he said.
Through a spokeswoman, the FDA declined to comment to the Times, citing regulations that prohibit disclosing information about drugs that are being developed.