Home Medizin LSD-basiertes Medikament gegen Angstzustände erhält FDA-Durchbruchsstatus

LSD-basiertes Medikament gegen Angstzustände erhält FDA-Durchbruchsstatus

von NFI Redaktion

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a Phase 2b clinical study. Mind Medicine (MindMed) Inc is developing the treatment MM120 (Lysergic-D-tartrate).

In a press release, the company reported that a single oral dose of MM120 achieved its key secondary endpoint, demonstrating a „clinically and statistically significant“ reduction in the Hamilton Anxiety Scale (HAM-A) score compared to placebo after 12 weeks, with a 65% clinical response rate and 48% clinical remission rate.

The company had previously announced statistically significant improvements in the HAM-A compared to placebo at the 4-week primary endpoint of the study.

Dr. David Feifel, a study researcher and emeritus Professor of Psychiatry at the University of California, San Diego, noted the remarkable effectiveness of MM120 in treating anxiety and expressed optimism for future Phase 3 studies.

The study participants received a single dose of MM120 in a controlled clinical setting without additional therapeutic intervention. Prior to treatment, participants were gradually tapered off any anxiolytic or antidepressant medications and did not receive any study-related psychotherapy during their participation.

The 100 µg dose of MM120 showed optimal clinical activity, leading to a significant improvement compared to placebo at week 12. The treatment was generally well-tolerated, with most adverse events being mild to moderate and transient.

The company plans to hold an end-of-Phase-2 meeting with the FDA in the first half of 2024 and commence Phase 3 trials in the second half of 2024. The primary data analysis of the study will be presented at the annual meeting of the American Psychiatric Association (APA) in May.

Robert Barrow, Director and CEO of MindMed, highlighted the FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the promising data from the Phase 2b study, underscoring the potential of this treatment in meeting the unmet needs of individuals with GAD.

Related Posts

Adblock Detected

Please support us by disabling your AdBlocker extension from your browsers for our website.