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FDA panel rejects MDMA therapy for treating patients with PTSD

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An independent advisory panel of the Food and Drug Administration on Tuesday rejected the use of MDMA-assisted therapy for patients with post-traumatic stress disorder.

The committee is comprised of independent mental health experts, The Washington Post reported. Their vote is not binding.

The panel’s decision was a setback for what could be the first psychedelic treatment approved by the FDA, according to the newspaper.

By a 9-2 vote, the committee said the data does not show that the drug, commonly called Ecstasy or Molly, is effective in treating PTSD, The New York Times reported. By a 10-1 decision, committee members said the benefits of MDMA do not outweigh the risks, according to the newspaper.

Prior to the vote, panel members said they were concerned about the two designs submitted by Lykos Therapeutics, the drug’s sponsor. They were troubled that study participants were mostly able to correctly guess whether they had been given MDMA, the Times reported.It seems like there are so many problems with the data -- each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, said during the meeting.

Prior to the vote, panel members said they were concerned about the two designs submitted by Lykos Therapeutics, the drug’s sponsor. They were troubled that study participants were mostly able to correctly guess whether they had been given MDMA, the Times reported.

“I absolutely agree that we need new and better treatments for PTSD,” Paul Holtzheimer, deputy director for research at the National Center for PTSD who had the lone “no” vote on the second question before the committee. “However, I also note that premature introduction of a treatment can actually stifle development, stifle implementation and lead to premature adoption of treatments that are either not completely known to be safe, not fully effective or not being used at their optimal efficacy.”

An approval by the FDA would mark a major milestone for advocates of MDMA, who contend that psychedelic drugs could successfully treat several mental health disorders, the Post reported.

MDMA is currently classified as a Schedule I drug under the Controlled Substances Act, according to CNN.

Jason Pyle, an independent doctor who serves as an unpaid member of Lykos’ board, cautioned the FDA committee against missing the big picture, according to the newspaper.

“In any pharmaceutical there are risks and questions, which is why we need the regulatory framework,” Pyle said. “In the face of a veteran suicide epidemic and a community mental health crisis, we have to confront this with compassion, clarity and bravery.”

PTSD is a condition that affects an estimated 13 million people in the United States, the Post reported.

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