Iris Cole interviews Dr. Oren Tana about depression and its treatment / Walla system
For the first time, the FDA - the American Food and Drug Administration, granted breakthrough treatment status to an LSD formulation found to relieve symptoms of anxiety and depression in a single dose.
Mind Medicine's MM120 (Lysergide d-tartrate) is used to treat generalized anxiety disorder.
The research findings showed that 12 weeks after receiving a single dose in a phase 2 trial, 48% of patients were in remission and 65% saw a significant improvement in 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 Chief Medical Officer Dr. Daniel Carlin, an assistant professor of psychiatry at Tufts University School of Medicine, told CNN. "This occurred across all levels of anxiety." , from moderate to severe."
According to him, "the designation - breakthrough is recognition that a drug has demonstrated evidence of clinical effectiveness in responding to an unmet medical need with morbidity and mortality associated with it."
Two other companies also received FDA breakthrough treatment status: Psilocybin, found in mushrooms, for treatment-resistant depression and MDMA, commonly known as ecstasy or molly, for post-traumatic stress disorder or PTSD.
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Today's standard of care includes cognitive behavioral therapy, sedatives, and drugs that affect serotonin in the brain, including buspirone and selective serotonin reuptake inhibitors.
But patients may have to experiment with different doses, adding more time and costs to treatment, Carlin says.
MM120 works via a single tablet that dissolves on the tongue under supervision, but without treatment.
This is the first study to show that "a single dose of LSD can effectively treat generalized anxiety without the addition of psychotherapy," researcher Gabriela Gobi, a psychiatry at McGill University who was not involved in the study, told CNN.
The FDA is granting the new designation to "expedite the development and review" of a drug that "treats a serious or life-threatening condition" and is demonstrated by preliminary clinical evidence "demonstrating a significant improvement in a clinically meaningful endpoint compared to available treatments."
MindMed expects to begin Phase 3 trials before the end of the year.
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