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FDA panel rejects MDMA therapy for treating patients with PTSD Boston 25 News [Video]

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Treatment Options

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 Timesreported.It seems like there are so many problems with the data …

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