The U.S. Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), based on the data submitted by Lykos Therapeutics.Â
The FDA determined that there was inadequate evidence to support the safety and efficacy of MDMA-assisted therapy for PTSD. This decision followed a recommendation from an independent advisory panel, which cited concerns about the integrity and design of the clinical trials conducted by Lykos Therapeutics.
The advisory committee highlighted several issues with the clinical trials, including potential biases in efficacy assessments and functional unblinding, where participants and therapists could likely identify who received MDMA versus a placebo. There were also concerns about the durability of the treatment’s effects and the potential for misuse of the drug.
The FDA and its advisory committee expressed concerns about the potential severe health risks associated with MDMA, such as cardiovascular complications. The need for more comprehensive safety data was emphasized.
The FDA has requested that Lykos conduct an additional Phase 3 trial further to study the safety and efficacy of MDMA-assisted therapy. This trial is expected to take several years to complete.
The FDA’s decision to decline approval for MDMA-assisted therapy for PTSD highlights the challenges and scrutiny faced by psychedelic therapies in the regulatory process. While the decision is a setback for Lykos Therapeutics, it also sets the stage for further research and development in this promising field, with the hope of eventually providing new, effective treatment options for those suffering from PTSD.
