FDA Set to Approve or Deny MDMA Medication By August 2024

In December 2023, the FDA received a New Drug Application (NDA) to treat Post-Traumatic Stress Disorder (PTSD). But what makes this application unique is the fact that the proposed drug is MDMA, aka “ecstasy.” MDMA is a Schedule I substance under the Controlled Substances Act, which means that MDMA is labelled as having no accepted medical use and that its unsafe even under medical supervision. The NDA was submitted after results were gathered from two randomized, double-blind, placebo-controlled Phase III trials that examined the efficacy and safety of MDMA-assisted therapy to treat moderate to severe PTSD. According to the company that submitted the NDA, the intent would be that the drug would be administered in a clinical setting and include a therapy session. 

Last month, in February 2024, the FDA not only accepted the NDA for review, it granted the NDA priority review. The FDA set a deadline for it to act on the application by August 11, 2024. If the FDA ultimately approves MDMA as a treatment for PTSD, it will mean that MDMA should be re-scheduled under the Controlled Substances Act, because, after all, it would be false to say MDMA doesn’t have an accepted medical use.