Dutch Committee Seeks to Expedite MDMA-Assisted Therapy for PTSD
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. (SeeĀ Analysis: FDA Advisory Committee Snubs MDMA-Assisted Therapy for PTSD in Overwhelming āNoā 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. āThe government must act expeditiously to enable the therapeutic use of MDMA,ā read aĀ press release summarising the findings of the committeeās final report...
Join Today
Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and research.
- Regular Bulletins featuring news, analysis, and research
- Articles and deep dives across psychedelic drug development, policy, and research
- Exclusive interviews with researchers, executives, and policymakers
- Bespoke resources and tools including the Psychedelic Bill Tracker
- Quarterly video briefings and slide decks