After an FDA rejection, here’s what’s next in the psychedelics pipeline

BioPharma Dive August 28, 2024
Amy Baxter

By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.

The psychedelic drug field hit a setback this month when the Food and Drug Administration rejected Lykos Therapeutics’ application for approval of an MDMA-assisted therapy.

The rejection was not entirely unexpected, after advisers to the FDA had recommended against approval for several reasons, including concerns over drug abuse, alleged sexual misconduct during testing and Lykos’ failure to collect certain data the FDA requested.

While an approval would have been a notable milestone, Lykos’ disappointment could still prove instructive to other biotechnology companies advancing their own psychedelic therapies.

“The FDA’s decision has put the sector on notice that...

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