The Biden administration greenlit using LSD for breakthrough therapy status Thursday.
The U.S. Food and Drug Administration (FDA) moved forward in the process of approving the use of an LSD formula to treat generalized anxiety disorders, according to The Hill. Breakthrough therapy is a process used to speed up the development and review of drug treatments likely to improve serious conditions, according to the FDA.
U.S. Food and Drug Administration (FDA) grants breakthrough therapy status to LSD formula to treat generalized anxiety disorder after initial study shows that a single dose of the drug could provide lasting relief https://t.co/cfac6duX1B pic.twitter.com/rjfwQAsrh9
— The Hill (@thehill) March 7, 2024
Mind Medicine (MindMed) developed the LSD therapy that showed in a study that one dose of the drug may relieve symptoms of the mental health disorder, The Hill reported. The treatment is pending standard FDA approval and will eventually reportedly enter Phase 3 clinical trials.
The study showed that LSD 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,” a release about the drug treatment stated.
Common side effects seen in patients on the “dosing day” of the LSD treatment included hallucinations, euphoric mood, abnormal thinking, headaches, dizziness and nausea, according to the outlet. MindMed reportedly plans to update the FDA on its new therapy as it seeks to expand the program in the second half of the year.
Dr. David Feifel, a psychiatry researcher and an investigator in the LSD treatment study, called its results “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,” Feifel said in the pharmaceutical company’s press release. “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.”