Medical Professionals Reference (MPR)LSD Drug Candidate Gets Breakthrough Tx Status for Generalized Anxiety Disorder

Breakthrough in Mental Health: LSD’s New Role in Generalized Anxiety Disorder Management

The Food and Drug Administration’s recent grant of Breakthrough Therapy designation to MM120, a lysergide-based medication, marks a pivotal moment in the treatment of generalized anxiety disorder (GAD). This designation stems from compelling phase 2 trial results demonstrating MM120’s significant impact on reducing anxiety symptoms, offering a novel approach in the psychiatric management of GAD.

Key Points:

• The FDA has awarded Breakthrough Therapy designation to MM120 (lysergide d-tartrate) for treating generalized anxiety disorder (GAD).
• MM120 is a derivative of LSD, acting as a partial agonist at serotonin-2A receptors, suggesting a novel mechanism of action for anxiety treatment.
• The phase 2 study involved 194 patients with severe GAD, using a placebo-controlled, double-blind methodology to evaluate MM120’s efficacy.
• Participants showed a substantial reduction in anxiety, with a 7.6-point decrease in the Hamilton Anxiety rating scale (HAM-A) at week 4 for the 100mcg MM120 dose compared to placebo.
• By week 12, the 100mcg dose maintained its effectiveness, showing a 7.7-point improvement over placebo.
• Clinical Global Impressions – Severity (CGI-S) scores significantly improved with MM120, highlighting a notable shift from ‘markedly ill’ to ‘borderline ill’.
• Rapid onset of clinical activity was observed as early as day 2 post-administration.
• The treatment was associated with several adverse effects, including hallucinations, euphoria, and nausea, primarily occurring on the dosing day.
• Expert commentary emphasized MM120’s potential in transforming anxiety treatment, underscored by its sustained efficacy and rapid onset of action.
• MindMed is planning to initiate phase 3 trials in the latter half of 2024 to further explore MM120’s therapeutic potential.

“That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable.”
– David Feifel, MD, PhD, Professor Emeritus of Psychiatry at the University of California, San Diego

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