Marijuana Moment By Ben Adlin 3/8/2024
LSD-Like Drug Wins FDA ‘Breakthrough Therapy’ Status For Treatment Of Generalized Anxiety DisorderPromising results from a clinical trial of the LSD-like substance MM120 have persuaded the Food and Drug Administration (FDA) to award it “breakthrough therapy” status as a treatment for generalized anxiety disorder (GAD).
The drugmaker behind MM120—Mind Medicine Inc., or MindMed—said in a press release Thursday that it plans to hold an end-of-Phase 2 meeting with FDA in the first half of 2024 and begin a Phase 3 clinical trial in the second half of the year.
Results of the latest round of study showed that a single oral dose of MM120 (lysergide d-tartrate) led to “clinically and statistically significant” reductions in anxiety scores 12 weeks after administration, with 65 percent of participants showing a clinical response and 48 percent in clinical remission following the treatment.
Breakthrough drug status is meant to recognize the therapeutic promise of an emerging substance or therapy as well as speed the research and development of treatments that fill an unmet need. MDMA and psilocybin have also previously been awarded the designation.
“That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” David Feifel, professor emeritus of psychiatry at the University of California San Diego and an investigator in the latest MindMed study. “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.”
Unlike leading psychedelic-assisted therapies, such as the use of MDMA to treat PTSD, trials into the efficacy of MM120 did not include a talk therapy or psychotherapy component. “MM120 was administered as a single dose in a monitored clinical setting with no therapeutic intervention,” MindMed said.
“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,” MindMed’s director and CEO, Robert Barrow, said in a statement. “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.”
More:
https://www.marijuanamoment.net/lsd-like-drug-wins-fda-breakthrough-therapy-status-for-treatment-of-generalized-anxiety-disorder/
