FDA accepts BioXcel Therapeutics application for IGALMI in at-home agitation treatment
#FDA #BioXcel Therapeutics #IGALMI #agitation #at-home treatment #dexmedetomidine #TRANQUILITY II
📌 Key Takeaways
- FDA accepted BioXcel Therapeutics' application for IGALMI as an at-home treatment for agitation.
- IGALMI is a sublingual film formulation of dexmedetomidine designed for acute agitation.
- The application is based on positive results from the Phase 3 TRANQUILITY II trial.
- If approved, IGALMI could provide a new at-home treatment option for agitation episodes.
🏷️ Themes
FDA Approval, Mental Health, Pharmaceuticals
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