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.
Drug company Lycos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that regulators had requested an additional Phase 3 trial to further study the treatment’s safety and effectiveness. The decision came after an FDA advisory committee concluded in June that there wasn’t 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 another study is deeply disappointing not only for all those who dedicated their lives to this pioneering work, but also for the millions of Americans with PTSD and their families who have been without new treatment options for more than 20 years,” Lycos CEO Amy Emerson said in a company statement. Emerson added that conducting another Phase 3 trial would 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 a letter to President Biden, more 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.”
This week, a bipartisan group of more than 60 House members and 19 senators also voiced their support for the treatment. “Given the high burden of PTSD and the limitations of current treatments, the possibility of new, more effective therapies is particularly significant,” the lawmakers 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.”
At a nine-hour meeting on June 4, Lycos representatives made their case to an independent FDA advisory committee. According to data from the company’s clinical trials, more than 86 percent of subjects who received MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved to the point where they no longer met 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 any scientific disagreements,” Lycos said in a statement.
