LSD Treatment Receives Breakthrough Therapy Status for Anxiety
The FDA has granted breakthrough therapy status to the LSD-like substance MM120, developed by Mind Medicine Inc., to speed up the development and review for the treatment for generalized anxiety disorder (GAD). MM120 - a tartrate salt form of lysergide (commonly known as LSD) - has shown encouraging results in clinical trials where a single oral dose led to significant reductions in anxiety scores 12 weeks after administration, with a significant percentage of participants showing clinical response and remission.
The following article originally appeared in Forbes.
The U.S. Food and Drug Administration last week granted “breakthrough therapy” status to a form of the psychedelic drug LSD as a treatment for anxiety. The drug, a form of LSD (lysergide d-tartrate) designated as MM120, is being developed by biopharma company MindMed as a treatment for general anxiety disorder (GAD), a condition characterized by persistent and severe worry about aspects of day-to-day life.
The FDA’s designation of MM120 as a breakthrough therapy for GAD is based on data from a recent phase 2b clinical trial of the drug conducted by MindMed. The primary data analyses from the study have been accepted for presentation at the American Psychiatric Association’s annual meeting in May and the research is being submitted for publication in a leading medical journal, MindMed said in a statement about the development.
One Dose Reduced Anxiety Symptoms
In a report on the research, the company said that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” score reductions in the Hamilton Anxiety Scale (HAM-A, a commonly used psychiatric diagnostic tool) compared with a placebo. Improvement was noted within two days of administration of the drug, with further improvement observed at four weeks and 12 weeks into the study. At 12 weeks, the data indicated a 65% clinical response rate and 48% clinical remission rate.
“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. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” MM120 study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California San Diego, said in a statement from MindMed about the research. “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.”
LSD Drug Could Fill ‘Unmet Medical Need’
Dr. Daniel Karlin, assistant professor of psychiatry at Tufts University School of Medicine in Boston and MindMed chief medical officer, explained that the FDA’s designation of MM120 as a breakthrough therapy is also based on the substantial need for effective treatments for GAD, especially in patients who do not respond to or tolerate currently available medications.
“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,” Karlin told CNN.
The drug will still have to complete the FDA’s standard drug approval process, including phase 3 clinical trials. The breakthrough therapy designation, however, “is an offer from the agency to engage more closely in drug development,” Karlin said. “It affects timelines of response and our ability to get more interactions with the agency so that we can be sure that we’re in lockstep agreement as we move forward.”
Generalized Anxiety Disorder Affects Millions Of Americans
GAD affects about 6.8 million adults in the United States, yet only about 43% are receiving treatment, according to information from the Anxiety & Depression Society of America. Despite the prevalence of the condition, there has been little innovation in the treatment of GAD in the past two decades, with the last new drug approval occurring in 2004.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said Robert Barrow, CEO and director of MindMed. “We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”
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