The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to an LSD formula to treat generalized anxiety disorder after an initial study has shown that a single dose of the drug could provide lasting relief.
The LSD therapy developed by Mind Medicine Inc. (MindMed) must still go through the standard FDA approval process and will soon enter Phase 3 clinical trials.
The study that prompted FDA advancement found the drug was “generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug,” according to a release on the findings.
The most common adverse effects on the initial “dosing day” — or when patients were first given the drug — included hallucinations, euphoric mood, abnormal thinking, headache, dizziness and nausea, among others.
The company plans to meet for an update with the FDA in the coming months and begin an expanded clinical program in the second half of the year.
MindMed, a pharmaceutical company focused on developing psychedelic drugs into medicines, has spent years researching possible medicinal uses for LSD, an illicit drug that has never been approved for medicinal use. The specific LSD formula from the study is dubbed MM120.
Dr. David Feifel, a California-based psychiatry researcher who was an investigator in the study, called the findings “truly remarkable.”
“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety,” he said in a statement provided by the company. “These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.”
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