One dose of LSD in a clinical trial significantly improved anxiety and lasted for 12 weeks, convincing the FDA to give the drug a breakthrough therapy designation.
A clinical trial’s encouraging results won US Food and Drug Administration breakthrough therapy status for an LSD formulation to treat generalized anxiety disorder, Mind Medicine Inc. announced Thursday. The biopharmaceutical company is developing the drug. “A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it,” said Dr.
“We saw rapid and robust improvement on depression symptoms in people — depression and anxiety have overlapping disease definitions.” No use of psychotherapy Most research with MDMA and psilocybin has relied on the use of trained therapists who meet and establish a rapport with participants before the drug is administered. Those therapists are then on hand during the “trip” to help each person assimilate the experience, thus helping assure the lasting impact of any psychological insights.
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