AI-assisted development of "old drug new use" approved by FDA

BioXcel Therapeutics announced today that the U.

Up to 25% of people with schizophrenia and bipolar disorder experience agitation, which can range from 10 to 17 episodes per year, placing a heavy burden on patients, caregivers, and the healthcare system

Igalmi is a sublingual film formulation of the selective alpha2 adrenergic agonist dexmedetomidine, which is rapidly acting upon oral absorption

FDA approval is based on the results of two pivotal, randomized, double-blind, placebo-controlled Phase 3 clinical trials

▲Igalmi's Phase 3 clinical trial results (Image source: BioXcel's official website)

"Igalmi is the first new acute therapy in nearly 10 years to treat agitation associated with schizophrenia or bipolar I/II disorder and represents a differentiated model for helping patients manage this symptom

References:

[1] BioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults.

[2] A Win for AI: FDA Approves BioXCel Therapy for Bipolar Disorder and Schizophrenia.