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FDA clears LSD-based anxiety drug for clinical trials

January 26, 2022, 3:58 PM UTC

Several decades after Timothy Leary began evangelizing the benefits of LSD, the Food and Drug Administration is looking into the drug’s benefits.

The FDA has cleared a phase 2b study of an anxiety treatment that uses a pharmacologically optimized form of LSD. Mind Medicine (also known as MindMed), the biopharmaceutical company that developed the drug, says it expects clinical trials to start “in early 2022.”

“This trial, the first commercial study of LSD in more than 40 years, builds on productive discussions with FDA and provides an opportunity to explore improvements in anxiety symptoms,” said MindMed CEO and director Robert Barrow in a statement.

The experimental drug, called MM-120, focuses on generalized anxiety disorders and other brain-based disorders. Phase 2b trials are designed to test the efficacy of a drug, looking at its success rate in treating a disorder or disease.

In the case of MM-120, MindMed says it will begin a dose-optimization trial with 200 patients, which will guide dose selections in Phase 3 trials (which generally involve a larger number of patients and look at how a medicine works compared to existing treatments). Researchers hope to determine how much the LSD-based drug reduces anxiety symptoms over 12 weeks after a single dose.

LSD isn’t the only psychedelic drug MindMed is looking to bring to clinical use. Its pipeline also includes products that use psilocybin (aka “magic mushrooms”), MDMA (Molly or Ecstacy) and DMT, a hallucinogenic drug that occurs naturally in many plants and animals.

“With a clear regulatory path, we look forward to building on this momentum and advancing this trial as quickly and efficiently as possible,” said Barrow, “bringing us significantly closer to transforming the treatment landscape for patients who suffer from anxiety.”

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