How does the new 57-77 million annual agitation episodes estimate impact IGALMI®'s market potential?

The new estimate of 57-77 million annual agitation episodes significantly expands the potential market for IGALMI® (dexmedetomidine) sublingual film, particularly in the at-home setting. This revised figure represents a substantial increase from the previously anticipated 23 million annual episodes.1

IGALMI® is a prescription medicine developed by BioXcel Therapeutics for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.1 While currently administered under the supervision of a healthcare provider in institutional settings, BioXcel Therapeutics is actively pursuing a label expansion for at-home use through its SERENITY At-Home Phase 3 safety trial.1

The previous estimate of 23 million annual episodes was based on historical claims data, which BioXcel Therapeutics believes likely underestimated the actual frequency of agitation episodes due to a lack of approved treatment options in the at-home setting.1 Recent market research indicates that patients experience approximately three agitation episodes per month in the home setting, a figure higher than the 1.2 episodes per patient per month suggested by older claims data.2

This updated and higher estimate for at-home agitation episodes suggests a considerably larger total addressable market for IGALMI® should it secure approval for at-home administration.1 BioXcel Therapeutics views this expanded market opportunity as a foundation for meaningful, long-term growth and value creation as they work to make the drug accessible to patients in their homes.1