FDA: LSD Is Now a Breakthrough Therapy

Mind Medicine's anxiety-treating MM120 granted designation ahead of Phase 3 trials
By Arden Dier,  Newser Staff
Posted Mar 9, 2024 5:15 PM CST
FDA Recognizes LSD as a Breakthrough Therapy
A man holds a white pill in this stock photo.   (Getty Images/vladans)

The FDA has bestowed breakthrough therapy status on an LSD formulation found to relieve symptoms of anxiety and depression with a single dose. Mind Medicine's MM120 (lysergide d-tartrate) is used to treat generalized anxiety disorder. Twelve weeks after receiving a dose in a Phase 2 trial, 48% of patients were in remission and 65% saw significantly improved symptoms, according to the company. "The clinical improvement for many patients was more than double what we see with today's standard of care," MindMed's chief medical officer, Dr. Daniel Karlin, assistant professor of psychiatry at Tufts University School of Medicine, tells CNN. "This occurred at all levels of anxiety, from moderate all the way up to severe."

Today's standard of care includes cognitive behavioral therapy, sedatives, and medications that affect serotonin in the brain, including buspirone and selective serotonin reuptake inhibitors. But patients may need to experiment with doses, adding time and extra costs to treatment, Karlin says. MM120 works through a single tablet dissolved on the tongue under supervision, but without psychotherapy, per Inc. Indeed, this is the first study to show "a single dose of LSD … can effectively treat generalized anxiety without the adjunct of psychotherapy," Gabriella Gobbi, a psychedelics researcher at McGill University who was not involved in the trial, tells CNN.

Given the breakthrough status designation, MindMed now "expects to receive an influx of investment to the tune of $175 million," Inc. reports. The FDA grants the designation to "expedite the development and review" of a drug "that treats a serious or life-threatening condition" and is shown by preliminary clinical evidence to "demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies." MindMed expects to begin Phase 3 trials before the end of the year. (More LSD stories.)

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