Coverage by Oliver Longstaff for Pα+, edited by Josh Hardman.
Last month, we learned that the Psychopharmacologic Drugs Advisory Committee (PDAC), convened by the FDA to advise on the potential approval of MDMA-assisted therapy to treat patients with PTSD, had delivered a negative verdict: 10-1 against the notion that the therapeutic benefits outweigh the risks involved. The primary concerns highlighted by the committee included functional unblinding, trial design questions, adverse events and their reporting, and the abuse potential of MDMA. (See Analysis: FDA Advisory Committee Snubs MDMA-Assisted Therapy for PTSD in Overwhelming “No” Vote.)
Receiving a positive backing from an FDA advisory committee would have marked a watershed moment in the history of psychedelic medicine, for it could mean vindication from the regulatory establishment that molecules like MDMA could serve as safe and effective treatment modalities. It could also have finally portended the approval of a psychedelic-based therapy by the FDA. For now, we must wait and see.
Dutch Committee Takes A Different Stance
But a Dutch advisory committee has recently announced it is taking a different stance on MDMA-based interventions, recommending that the incoming government enables its use for treating patients with PTSD. “The government must act expeditiously to enable the therapeutic use of MDMA,” read a press release summarising the findings of the committee’s final report.
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