Panel advising US regulator rejects MDMA as treatment for post-traumatic stress disorder

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A panel of experts convened by the US Food and Drug Administration voted resoundingly against the use of MDMA, better known as the party drug ecstasy, as a treatment for post-traumatic stress disorder.

The ruling was a major setback for Lykos Therapeutics, the biotech developing the treatment, and the nascent psychedelics sector, which has received hundreds of millions of dollars in investments in recent years.

After a nine-hour evidence session, the FDA advisory committee, made up of medical and mental health experts, voted by a 9-2 margin that available data did not show the drug was an effective treatment for the disorder. post-traumatic stress disorder in combination with therapy. In a second vote, the panel also concluded that the benefits of the treatment did not outweigh the risks, by a vote of 10 to 1.

The FDA is due to make its final decision in mid-August. The panel’s vote is non-binding, but typically has great influence on the agency and will therefore dramatically reduce the likelihood of the treatment being approved, dashing the hopes of psychedelic advocates and investors.

Amy Emerson, CEO of Lykos, said in a statement: “We are disappointed by today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical task, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention.”

If approved, Lykos’ MDMA-based therapeutic treatment would have become the first new treatment for post-traumatic stress disorder in more than two decades. It would also have marked the first time that a Schedule 1 drug, which the government considers to have no medical application and a high potential for abuse, would have been approved as a regulated mental health treatment.

Earlier this year, Lykos, which emerged from the nonprofit Multidisciplinary Association for Psychedelic Studies, raised $100 million from a group of 10 investors, including the charitable foundation run by hedge fund billionaire Steven Cohen and his wife, Alexandra.

In the second of two Phase 3 trials, treatment with Lykos showed that 71 percent of people who had received its MDMA-based therapy improved enough to no longer meet the criteria for a diagnosis of post-traumatic stress disorder. , compared to 48 percent in the placebo group. Patients received the drug during three eight-hour therapy sessions.

But the FDA panel was unconvinced and voted against endorsing the treatment’s effectiveness, citing problems with the trial design and data collection.

Rajesh Narendran, a professor of radiology and psychiatry at the University of Pittsburgh School of Medicine, who chaired the panel, said problems with the trial design made the data “meaningless.” “There were too many problems (with the study),” added Satish Iyengar, a statistics professor at the University of Pittsburgh.

Tiffany Farchione, an FDA official, previously told the panel that Lykos had not collected data on the drug’s side effects associated with abuse, which the company had considered positive, such as “euphoria” or “euphoric mood,” which This means that it is difficult to accurately label the medication. Farchione said data collection issues “may have the biggest impact” on the agency’s decision.

David Millis, a clinical reviewer for the FDA, also expressed concern about participants in “double-blind” trials because of MDMA’s powerful hallucinatory effects. “Although we have two positive studies, the results are in the context” that the participants knew they were taking the drug, Millis said. Farchione also noted that the trial had not adequately evaluated the effect of psychotherapy on the treatment, as well as the possible cardiological risks of the treatment.

Alia Lilienstein, senior medical director at Lykos, rejected the criticism during the testing session. Before the hearing, two influential nonprofit organizations — the Institute for Clinical and Economic Review and a branch of the American Psychological Association — had also criticized the Lykos treatment.

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