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. He said on Friday The regulatory agency has requested an additional phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel concluded in June that there was insufficient evidence to recommend its approval.
Lykos said it plans to request a meeting with the FDA to ask for the decision to be reconsidered and to further discuss the agency’s recommendations. “The FDA’s request for another study is deeply disappointing, not only to all those who dedicated their lives to this pioneering effort, but most importantly to the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in more than two decades,” Lykos CEO Amy Emerson said in a statement. Company statementHe added that conducting another Phase 3 trial would take several years.
According to the National Center for PTSD, about 13 million Americans suffer from PTSD each year. Only two drugs have been specifically approved to treat the disorder, the last of which received the green light from the FDA in 2000. The lack of options has made veterans unlikely advocates for 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 BidenMore than 300 veterans and representatives from veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for 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 House members and 19 senators also expressed their support “Given the substantial burden of PTSD and current treatment limitations, the potential for new and more effective therapies is particularly 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 illness. But with the FDA’s decision, MDMA will remain a federally banned substance and will be listed as a Schedule I drug, defined as having “no currently accepted medical use and a high potential for abuse.”
During a Nine-hour meeting on June 4Lykos representatives presented their case to an independent FDA advisory panel. clinical trial data Results of one study showed that more than 86 percent of participants who underwent MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough to no longer meet criteria for a diagnosis. In a placebo group, 69 percent improved and nearly 48 percent no longer met the criteria for a PTSD diagnosis.
Despite the positive results, advisory committee members raised concerns about the reliability of 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 to what extent talk therapy contributes to the benefits of the treatment.
The panel voted overwhelmingly that there was insufficient evidence to recommend approval. Only two of the 11 committee members agreed that MDMA-assisted therapy is effective based on the evidence presented by Lykos, and only one thought its benefits outweighed the risks. The FDA generally follows the recommendations of advisory committees, but is not required to do so.
Lykos said it will “work diligently in the coming months to address FDA’s concerns and leverage the agency’s processes for resolving scientific disagreements.”