Advisers to the federal agency regulating drugs stated Tuesday that the combination of psychedelic ecstasy and therapy is not an effective treatment for post-traumatic stress disorder and that its use puts patients at risk of serious side effects. An expert advisory committee voted 9-2 that Lykos Therapeutics’ combination regimen of talk therapy and MDMA, the technical name for the drug, is not an effective treatment for PTSD. They also voted 10-1 that the therapy's risks outweigh its benefits, Politico reports. “Premature introduction of a treatment can actually stifle development and stifle innovation,” said Dr. Paul Holtzheimer, a member of the committee and deputy director for research in the executive division of the Department of Veterans Affairs’ National Center for PTSD. If the FDA follows its advisers, as it typically does, it could disrupt an emerging industry that is already relying on the use of various psychoactive drugs to treat disorders such as depression and anxiety.
Advisers found that there were concerns about expectation bias in Lykos' trials, as well as missing safety data, allegations of trial manipulation, and potential misconduct risk among therapy practitioners. After the advisory committee votes, Lykos CEO Amy Emerson said the firm was disappointed but “committed to continuing to collaborate with the FDA with their ongoing review.” She said Lykos was in ongoing discussions with the FDA about a risk evaluation and mitigation strategy program that would seek to reduce the chance of adverse events stemming from its treatment. In April, a citizen petition from psychedelic researchers critical of Lykos called on the FDA to hold an extended open public hearing so that the advisory committee could hear the public’s concerns. The advisers’ decision may dash hopes in Congress and at the Department of Veterans Affairs that Lykos’ protocol could help treat the mental illnesses that afflict more than a quarter of Americans, including people who served in the military. The FDA has previously designated MDMA and psilocybin, another psychedelic drug, as breakthrough therapies, a label meant to expedite their path toward approval. The FDA said it expects to make a decision by mid-August.