MDMA therapy reaches a roadblock – what’s the next step?

Nearly a year ago, thousands of people gathered in Denver, Colorado for the largest psychedelic conference in history. The atmosphere was electric, with most attendees convinced that the U.S. Food and Drug Administration (FDA) was on the verge of approving the first psychedelic drug.

But last week, the FDA dealt a devastating blow to proponents of psychedelic therapy when it rejected the use of the hallucinogen MDMA as a treatment for post-traumatic stress disorder (PTSD), citing concerns about safety and the validity of clinical trial results. The decision marks a pivotal moment for psychedelic science, raising questions about whether these drugs have a future in medicine, if at all.

California-based Lykos Therapeutics two Phase III Clinical Trials Clinical trials have shown that combining MDMA with talk therapy can significantly improve PTSD symptoms: A study of nearly 200 adults with moderate to severe PTSD found that 33 to 46 percent of subjects who received three doses of MDMA experienced relief from symptoms after two months, compared with less than a quarter of those who received talk therapy alone.

Taken at face value, these results are surprising. There are only two medications approved for the treatment of PTSD in the United States, and both only induce remission in 20 to 30 percent of cases. FDA Advisory Committee They questioned the study at a June meeting and ultimately voted 9-2 that the study did not prove MDMA's effectiveness.

One of the committee's main concerns was the lack of blinding techniques that would have prevented participants from knowing which treatment group they were in. About 90% of participants given MDMA and about 75% of those given a placebo were able to correctly guess which treatment they had received. This means that the placebo effect may have led participants in the MDMA group to expect and report improvements in their symptoms.

Another concern is the lack of detail about the potential risks of MDMA: Lykos Therapeutics submitted incomplete information about the drug's effects on the heart and did not collect data on its abuse risk.

Although all these issues likely led to the FDA's rejection of the drug, it doesn't mean the end of psychedelic drug research. First, the FDA has asked Lykos Therapeutics to re-run a Phase 3 trial of the MDMA-assisted therapy, suggesting that the agency is still open to such treatments. Researchers can also learn from this decision.

“Creating rigorous, reproducible science is crucial, and psychedelics are no exception.” David Yaden “If the advisory committee had had better reasons to trust the data, the outcome might have been quite different,” said a researcher at Johns Hopkins University in Maryland.

Lycos Therapeutics, meanwhile, is asking the FDA to reconsider its decision. “We're very disappointed that the FDA has asked for another study,” said Amy Emerson of Lycos Therapeutics. statement He noted that new studies will take years to complete and that the company maintains that many of the FDA's concerns can be addressed with existing data.