Anika Begay
The U.S. Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.
Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulator has requested an additional Phase 3 study so the therapy’s safety and effectiveness can be further studied. The move comes after an FDA advisory panel in June concluded there was insufficient evidence to recommend approval.
Lykos said it intends to request a meeting with the FDA to ask it to reconsider its decision and further discuss the agency’s recommendations. “The FDA’s request for another study is deeply disappointing, not only for all those who have dedicated their lives to this pioneering effort, but most importantly for the millions of Americans with PTSD and their loved ones who have not seen new treatment options in more than two decades,” Lykos CEO Amy Emerson said in a company statement. She added that conducting another Phase 3 study would take several years.
According to the National Center for PTSD, approximately 13 million Americans suffer from PTSD in any given year. Only two drugs have been approved specifically to treat the disorder, the last of which was green-lighted by the FDA in 2000. The lack of options has made combat veterans unlikely supporters of MDMA-assisted therapy. In the days leading up to the FDA’s decision, veterans groups and members of Congress from both parties lobbied for its approval.
In a letter to President Biden, more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope to veterans and their families, with the potential to save and dramatically improve countless lives for years to come.”
A bipartisan group of more than 60 members of the House of Representatives and 19 senators expressed support for the therapy this week. “Given the substantial burden of PTSD and the current limitations of treatment, the potential for new, more effective therapies is especially significant,” the lawmakers wrote in a letter to FDA Commissioner Robert Califf.
In recent years, there has been growing interest in using MDMA and other psychedelics to treat serious mental illnesses. But with the FDA’s decision, MDMA will remain a federally prohibited substance, listed as a Schedule I drug, defined as one that “has no currently accepted medical use and a high potential for abuse.”
During a nine-hour meeting on June 4, Lykos representatives presented their case to an independent panel of FDA advisors. Data from the company’s clinical trial showed that more than 86 percent of study participants receiving MDMA-assisted therapy experienced a measurable reduction in the severity of PTSD symptoms, and 71 percent improved enough to no longer meet the criteria for a diagnosis. In a placebo group, 69 percent improved, and nearly 48 percent no longer qualified for a PTSD diagnosis.
Despite the positive results, advisory committee members raised concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of talk therapy administered during MDMA sessions. One of the main questions raised by the advisory committee was the extent to which talk therapy contributes to the benefit of the treatment.
The panel overwhelmingly voted that there was insufficient evidence to recommend approval. Only two of the 11 committee members agreed that MDMA-assisted therapy was effective based on the evidence Lykos presented, and only one thought its benefits outweighed its risks. The FDA typically follows the recommendations of advisory panels, but it is not required to do so.
Lykos said it will “work diligently over the coming months to address FDA’s concerns and leverage the agency’s processes to resolve scientific disagreements.”
