Can MDMA still win FDA approval? Supporters rally as time runs out
By August 11 [2024], the Food and Drug Administration is expected to decide whether MDMA – the chemical found in ecstasy or molly – can be prescribed as a treatment for post-traumatic stress disorder.
The downvote in June [2024] – not to mention controversy about the trials that spilled into full view during a public hearing – has put the FDA in a tough spot. Heed its advisors’ recommendation and deny approval? Or greenlight the long-awaited decision on psychedelics? The agency has a range of options: Lykos could be required to submit additional data, or even run a new clinical trial, which could push back the timeline considerably. Alternatively, approval could come with the requirements to do post-market research, plus tight restrictions on how the drug is administered… even those in favor of approval are hesitant to make any predictions. “I would not hazard a guess,” says Harriet de Wit, a professor of psychiatry and behavioral neuroscience at the University of Chicago who has studied MDMA. “The FDA is faced with a very difficult decision that will set a precedent going forward.“
Original Article (NPR):
Can MDMA still win FDA approval? Supporters rally as time runs out
Artwork Fair Use: Harbin
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