Politico June 5, 2024
Driving the Day
TOUGH DAY FOR ECSTASY — An FDA advisory committee dealt a severe blow to psychedelic medicine on Tuesday, finding that MDMA, also known as ecstasy, is not an effective treatment for post-traumatic stress disorder, POLITICO’s Erin Schumaker reports.
The expert committee voted 9-2 that Lykos Therapeutics’ combo regimen of therapy and MDMA is not effective and 10-1 that the treatment’s risks outweigh its benefits.
“Premature introduction of a treatment can actually stifle development and stifle innovation,” said Dr. Paul Holtzheimer, committee member and deputy director for research in the executive division of the Department of Veterans Affairs’ National Center for PTSD.
The FDA typically follows the advice of its advisers in deciding whether to approve a new...
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