A Food and Drug Administration advisory panel on Tuesday overwhelmingly recommended against using the drug ecstasy combined with psychotherapy to treat PTSD, possibly derailing what would be the first psychedelic drug approval in the U.S.
Why it matters: While there's a growing effort to use hallucinogenic substances as behavioral health treatments, regulators are grappling with how to judge their safety and effectiveness, and there's a high risk for misuse.
- The FDA does not have to follow the advice of its advisory committees but usually does. The agency is expected to make a final decision on whether to approve the drug application from Lykos Therapeutics by Aug. 11.
The big picture: Nine of 11 advisory panel members after a daylong meeting voted that the data do not show that the MDMA-assisted therapy is effective in treating PTSD.
- Members raised concerns over missing safety data, allegations of misconduct in clinical trials, and the difficulty of figuring out how much the drug, rather than the psychotherapy it's paired with, was responsible for reported benefits.
- "It seems like there are so many problems with the data," said panel member Melissa Decker Barone, a psychologist at the VA Maryland Health Care System. "Each one alone might kind of be OK, but when you pile them up on top of each other … there's just a lot of questions."
The other side: Many mental health advocates and veterans during public comments urged the panel to endorse the treatment for PTSD, which affects about 13 million people in the U.S.
- It's been more than two decades since a new treatment was approved for the condition, and many people don't respond to existing therapies.
- MDMA "helped give me compassion for myself," said Nick Brown, a veteran who received the Lykos treatment in a clinical trial.
Some panel members who voted against the treatment expressed regret that, in their view, there wasn't enough evidence to support it.
- "I think this is a really exciting treatment. I'm really encouraged by the results to date," said Paul Holtzheimer, deputy director of research at the National Center for PTSD. "But I feel that both from an efficacy and a safety standpoint, it is still premature."
