The U.S. FDA denies approval for psychedelic drug treatment for PTSD.

On Friday, federal health regulators refused to approve the psychedelic drug MDMA as a treatment for PTSD, marking a significant setback for those advocating for the use of mind-altering substances to address serious mental health conditions.

Lykos Therapeutics revealed that the FDA has notified the company that their drug "cannot be approved based on the current data," and has requested an additional late-stage study. These studies usually span several years and involve substantial financial investment. The company intends to ask the agency to reconsider its decision.

The FDA's decision was anticipated after a government advisory panel overwhelmingly voted against approving the drug for post-traumatic stress disorder in June. The negative vote followed an all-day meeting where experts thoroughly examined Lykos' study data, research methods, and potential risks associated with the drug, including heart problems, injuries, and the possibility of abuse.

On Friday, the FDA stated that the MDMA application had "significant limitations" that "prevent the agency from concluding that the drug is safe and effective for the proposed indication." Despite this, the agency emphasized that it will continue to encourage "innovation for psychedelic treatments and other therapies to address these medical needs."