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During the daylong meeting, committee members praised the drug’s promise but also expressed confusion about gaps in research data, MDMA’s potential for abuse and how a psychotherapy not regulated by the FDA could be included in the drug’s approval.
“I think the therapy itself is still very much in the experimental stage,” said Paul Holtzheimer, deputy director for research at the National Center for PTSD, who voted against the treatment.
Lykos Therapeutics, the sponsor of the MDMA treatment, conducted two late-stage clinical trials that showed that patients who took the drug had significantly improved symptoms of PTSD compared with those who took a placebo. However, the data was unusually mixed. Participants in the clinical trials also received various forms of psychotherapy, but the results did not specifically measure the effects of those treatments. MDMA’s consciousness-distorting properties also complicate the gold standard of clinical trials, which require participants not to know whether they are taking the drug or a placebo.
“While we are disappointed with the outcome of the vote, we are committed to continuing to work with the FDA on its ongoing review,” Lykos CEO Amy Emerson said in a statement. “There is an urgent need for new, effective, accessible therapies to address this unmet need for patients with PTSD,” she added.
The drug’s approval would be a watershed moment for advocates who believe psychedelic drugs, best known for their effects on people’s hallucinations or ecstasy, can successfully treat a range of mental illnesses. Veterans and others with post-traumatic stress disorder have long championed MDMA’s potential. An estimated 13 million Americans suffer from PTSD, but few drugs are approved to treat the condition.
If the drug fails to win approval, it would be a huge setback for the psychedelic field and for the investors who have poured hundreds of millions of dollars into companies developing psychedelic drugs to treat mental illnesses.
Ahead of Tuesday’s advisory meeting, the FDA’s own staff raised Wide range of issues The committee voted 9-2 on Tuesday that the data did not show the drug was effective in treating PTSD, and 10-1 that the benefits did not outweigh the risks, even if the FDA came up with a plan to mitigate them.
Jason Pyle, an independent physician and unpaid member of the Lykos board, cautioned against losing sight of the bigger picture. “With any drug, there are risks and questions, and that’s why we need a regulatory framework,” he said. “In the face of the veteran suicide epidemic and the mental health crisis in our community, we must confront this with compassion, clarity and courage.”
Tiffany R. Farchione, an FDA official, told the panel Tuesday that although the agency has required Lykos to report abuse-related effects, the company has not reported effects such as “euphoria” or “elevated mood.” Fazione, director of the FDA’s psychiatry division, said describing MDMA’s effects for labeling or treatment recommendations would be challenging if the FDA approved the drug.
Falchione said the lack of data collection “will probably have the biggest impact on the agency’s decision.”
Lykos’ senior medical director, Alia Lilienstein, acknowledged Tuesday that the company does not document euphoria and related effects, but said if MDMA-assisted treatment approved. She also acknowledged that Lykos’ application was complex, adding: “Patients deserve our hard work and finding ways to move complex things forward.”
The federal government classifies MDMA as a Schedule I controlled substance with no recognized medical use and a high risk of abuse, putting it in the same category as heroin and LSD.
Lilienstein stressed that while MDMA’s potential for abuse is “moderately high,” it’s still lower than drugs like methamphetamine and doesn’t produce withdrawal symptoms.
Farchione also expressed concerns about the effectiveness of psychotherapy itself, since the FDA does not regulate psychotherapy. She added that while the agency cannot rule on MDMA for standalone use, “we also don’t have strong evidence that it’s necessary.”
Committee members pressed Lykos executives for the company’s treatment manuals and how therapists are evaluated. They also expressed concern about the condition of a female trial patient who explain In 2015, during a therapy session that crossed ethical boundaries, she was sexually assaulted by a male therapist whose wife was also a therapist.
“Let’s not sweep this misconduct under the rug — this is sexual misconduct,” said panelist and patient representative Elizabeth Joniak-Grant, a sociologist at the University of North Carolina at Chapel Hill.
The patient, Meaghan Buisson, testified by proxy on Tuesday, pointing to a publicly available video showing the therapist holding her down, hugging and touching her. In an earlier interview with The Washington Post, Buisson criticized the Multidisciplinary Association for Psychedelic Studies (MAPS), Lykos’s nonprofit parent, for failing to keep her safe, covering up harms and calling the therapies used in the trial “complete bullshit.”
“How much information does the world need before it realizes that MAPS can’t trust these substances?” Buisson said.
A nonprofit group affiliated with the American Psychological Association said in a letter to the FDA on Monday that it believes there is “insufficient evidence” for an advisory panel to recommend MDMA-assisted therapy for PTSD, citing concerns that the results could be biased by participants knowing whether they were taking the real drug or a placebo. This echoes the concerns of the influential nonprofit Institute for Clinical and Economic Review, which published a paper Draft Report This year it expressed “significant concerns” about the research supporting the drug’s approval.
Committee members have repeatedly addressed allegations of clinical trial misconduct raised by public spokespeople and the ICER report, including allegations that therapists discouraged patients from reporting adverse reactions. The FDA’s Farchione said the agency couldn’t talk about “what we’re investigating,” but added that officials were aware of the report and “certainly take these allegations seriously.”
Lykos officials said the drug’s rollout will be limited, and the FDA’s proposed restrictions include requiring it to be distributed only in certain medical settings, with a physician present during administration and at least two health care providers monitoring the patient’s physical and mental state for at least eight hours.
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