Joe McConnell
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U.S. drug regulators have rejected an application to approve MDMA, a Class 1 drug better known as ecstasy, as a treatment for post-traumatic stress disorder, marking a significant setback for the nascent psychedelic industry.
The U.S. Food and Drug Administration sent Lykos Therapeutics, the biotech company behind the treatment, a notice known as a “complete response letter” asking the company to conduct new, expensive phase three studies because of concerns about how the original studies were conducted.
Lykos said in a statement Friday that the agency’s concerns “echo” those raised by a panel of outside experts convened by the regulator in June. The FDA advisory panel voted overwhelmingly against approving the treatment that combined MDMA with therapy, citing concerns about how Lykos’ clinical trials were designed.
The FDA said that “there are significant limitations to the data in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”
Running new late-stage trials will likely cost Lykos tens of millions of dollars, forcing it to raise more money from investors or jeopardize its decades-long efforts to get MDMA approved as a treatment for PTSD. Lykos is the for-profit offshoot of a psychedelic advocacy group dating back to the 1980s.
In June, the FDA advisory panel highlighted the difficulties of ensuring that trial participants did not know they were taking the drug to avoid biasing the results, weakening Lykos’s claim that the study was “double-blind.” The panel voted nine to two that the data did not show that MDMA-assisted therapy was an effective treatment for PTSD and voted 10 to one that the benefits of the treatment did not outweigh the risks.
The FDA committee highlighted the possible cardiovascular risks associated with MDMA, as well as concerns that the study was tainted by the promotion of the psychedelic by some therapists, and the failure to collect data on long-term abuse problems caused by the drug.
“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, along with their loved ones, who have seen no new treatment options for more than two decades,” said Amy Emerson, Lykos’ chief executive officer.
About 13 million Americans, or about 3.5 percent of U.S. adults, suffer from PTSD, according to official statistics. PTSD sufferers, many of whom are military veterans, have benefited from few new treatments in recent years.
Lykos questioned the conduct of the FDA panel “including the limited number of subject matter experts on the panel and the nature of the discussion, which at times veered beyond the scientific content in the briefing documents” in his statement released Friday.
The company said it plans to request a meeting with the FDA to ask it to reconsider its decision and seek recommendations from the agency on how best to proceed with the resubmission. Lykos has previously conducted two phase three studies on the efficacy of MDMA as a treatment for PTSD.
