The U.S. Food and Drug Administration has rejected a first-of-its-kind proposal to operate the psychedelic drug MDMA, also known as ecstasy or Molly, to treat post-traumatic stress disorder.
Drugmaker Lykos Therapeutics has asked the FDA to approve the drug in combination with talk therapy. The company he said on Friday that the regulatory agency has requested an additional Phase 3 study so that the therapy’s safety and effectiveness can be studied further. The decision comes after an FDA advisory panel in June concluded there was insufficient evidence to recommend approval.
Lykos said it plans to request a meeting with the FDA to ask for a reconsideration of the decision and discuss the agency’s recommendations. “The FDA’s request for another study is deeply disappointing, not only for all those who 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 any new treatment options for more than two decades,” Lykos CEO Amy Emerson said in a statement. company statementShe added that it would take several years to conduct another phase 3 study.
According to the National Center for PTSD, 13 million Americans suffer from PTSD each year. Only two drugs have been specifically approved to treat the disorder, the last of which was greenlit by the FDA in 2000. The lack of options made war veterans unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pushed for its approval.
IN letter to president bidenMore than 300 veterans and veterans advocacy 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 also expressed their support for the therapy this week. “Given the significant burden of PTSD and the current limitations of treatment, the opportunity 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 psychedelic substances to treat earnest mental illnesses. However, the FDA’s decision meant that MDMA would remain a federally banned substance, listed as a Schedule I drug, defined as one that has “no currently accepted medical use and a high potential for abuse.”
While nine-hour meeting on June 4Lykos representatives presented their case to an independent panel of FDA advisors. The company clinical trial data showed that more than 86 percent of study participants who underwent MDMA-assisted therapy experienced measurable reductions in the severity of their PTSD symptoms, and 71 percent improved enough to no longer meet criteria for the diagnosis. In the placebo group, 69 percent improved, and nearly 48 percent no longer met criteria for a PTSD diagnosis.
Despite the positive results, advisory committee members expressed concerns about the reliability of clinical trial data, long-term treatment efficacy, and standardization of talk therapy used during MDMA sessions. One of the main questions raised by the advisory committee was to what extent talk therapy contributes to the treatment benefits.
The panel overwhelmingly found there was insufficient evidence to recommend approval. Only two of the 11 panel members agreed that MDMA-assisted therapy was effective based on the evidence presented by Lykos, and only one believed the benefits outweighed the risks. The FDA typically follows the recommendations of advisory committees, but it is not required to do so.
Lykos said it will “work aggressively to resolve FDA concerns in the coming months and will utilize the agency’s procedures to resolve scientific discrepancies.”