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MDMA therapy for PTSD rejected by FDA panel
https://www.nature.com/articles/d41586-024-01622-3NEWS
05 June 2024
MDMA therapy for PTSD rejected by FDA panel
Scientific advisers vote overwhelmingly that the risks of MDMA treatment for post-traumatic stress disorder outweigh the benefits.
By Sara Reardon
In a decision that shocked some observers, key advisers to the US Food and Drug Administration (FDA) voted that the effectiveness of the party drug MDMA for treating post-traumatic stress disorder is unproven.
Members of an independent scientific advisory committee voted 9 to 2 that human trials of MDMA did not prove its efficacy. They also voted 10 to 1 that the risks of MDMA, also known as ecstasy, outweigh its benefits. The FDA does not have to follow its advisory committee’s recommendations when deciding whether to approve a drug, but often does.
The vote highlighted the difficulty of assessing psychedelic drugs and the FDA’s limited ability to evaluate psychiatric treatments. “It felt strange to vote no,” says committee member and statistician Satish Iyengar at the University of Pittsburgh in Pennsylvania, given that the drug’s effects seemed so strong. “There were just too many problems with it.”
The meeting was held 4 June in Silver Spring, Maryland.
[...]
05 June 2024
MDMA therapy for PTSD rejected by FDA panel
Scientific advisers vote overwhelmingly that the risks of MDMA treatment for post-traumatic stress disorder outweigh the benefits.
By Sara Reardon
In a decision that shocked some observers, key advisers to the US Food and Drug Administration (FDA) voted that the effectiveness of the party drug MDMA for treating post-traumatic stress disorder is unproven.
Members of an independent scientific advisory committee voted 9 to 2 that human trials of MDMA did not prove its efficacy. They also voted 10 to 1 that the risks of MDMA, also known as ecstasy, outweigh its benefits. The FDA does not have to follow its advisory committee’s recommendations when deciding whether to approve a drug, but often does.
The vote highlighted the difficulty of assessing psychedelic drugs and the FDA’s limited ability to evaluate psychiatric treatments. “It felt strange to vote no,” says committee member and statistician Satish Iyengar at the University of Pittsburgh in Pennsylvania, given that the drug’s effects seemed so strong. “There were just too many problems with it.”
The meeting was held 4 June in Silver Spring, Maryland.
[...]
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