Lykos’ MDMA-Assisted Therapy Faces Landmark Adcomm

Pill bottle, psychedelic background_Nicole Bean

Pictured: A prescription bottle over a groovy neuro background/ Nicole Bean for BioSpace

On Tuesday, an FDA advisory committee will meet to discuss the relative merits of Lykos Therapeutics’ psychedelic-assisted therapy for post-traumatic stress disorder—the first therapeutic for PTSD to undergo FDA scrutiny in this century.

The recommendation of the FDA’s Psychopharmacologic Drugs Advisory Committee is non-binding and will be considered by the FDA on August 11, when it completes its New Drug Application evaluation.

An approval of MDMA (3,4-methylenedioxymethamphetamine)— perhaps better known as ecstasy—to treat PTSD is expected to send major vibrations through the mental health community. The repercussions will affect not only treatment but research and are likely to spill over to other emerging psychedelic-assisted therapies.

MDMA was developed in 1912 but didn’t really start to gain use in psychiatric practice until the 1970s and 1980s,” Sam Clark,…
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