The U.S. Food and Drug Administration has rejected the first-ever proposal to use the hallucinogen MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.
The drug company, Lycos Therapeutics, had asked the FDA to approve the drug in combination with talk therapy. said on Friday Regulators called for additional Phase 3 trials to further study the treatment’s safety and effectiveness. The decision came after an FDA advisory committee concluded in June that there was not enough evidence to recommend approval.
Lycos said it plans to request a meeting with the FDA to ask for a reconsideration of its decision and to further discuss the agency’s recommendations. “The FDA’s request for new studies is deeply disappointing not only for all those who dedicated their lives to this pioneering work, but also for the millions of Americans living with PTSD and their families who have been without new treatment options for more than 20 years,” Lycos CEO Amy Emerson said in a statement. Company StatementShe added that further phase 3 trials will likely take several years.
According to the National PTSD Center, as many as 13 million Americans suffer from PTSD each year. There are only two drugs approved to treat the disorder, the most recent of which was approved by the FDA in 2000. With few options, combat veterans have become unlikely advocates of MDMA-assisted therapy. In the days leading up to the FDA’s decision, veterans’ groups and lawmakers from both parties urged for approval.
in Letter to President BidenMore than 300 veterans and representatives of veterans advocacy groups wrote that MDMA-assisted therapy “provides much-needed hope to veterans and their families, with the potential to save and dramatically improve countless lives in the years to come.”
A bipartisan group of more than 60 House members and 19 senators also expressed support The lawmakers petitioned for approval of the treatment this week. “Given the high burden of PTSD and the limitations of current treatments, the potential for new, more effective therapies is particularly significant,” they wrote in a letter to FDA Commissioner Robert Califf.
There has been growing interest in using MDMA and other hallucinogens to treat serious mental illnesses in recent years, but the FDA’s decision means MDMA will remain a federally banned substance as a Schedule I drug, defined as one that has “no currently accepted medical use and a high potential for abuse.”
During the period 9-hour meeting on June 4thRepresentatives from Lycos presented their case to an independent panel of FDA advisers. Clinical Trial Data The study found that more than 86 percent of study participants who received MDMA-assisted treatment experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough to no longer meet diagnostic criteria. In the placebo group, 69 percent improved, and nearly 48 percent no longer met PTSD diagnostic criteria.
Despite the positive results, advisory committee members expressed concerns about the reliability of the clinical trial data, the long-term effectiveness of the treatment, and the standardization of talk therapy conducted during MDMA sessions. One of the major questions raised by the advisory committee was the extent to which talk therapy contributes to therapeutic outcomes.
The committee voted overwhelmingly that there was insufficient evidence to recommend approval. Based on the evidence presented by Lycos, only two of the 11 committee members agreed that MDMA-assisted therapy would be effective, and only one thought the benefits outweighed the risks. The FDA typically follows the recommendations of its advisory committees, but is not required to do so.
“We will work diligently in the coming months to address the FDA’s concerns and utilize the agency’s processes to resolve scientific disagreements,” Lycos said in a statement.
