The new estimate of 57-77 million annual agitation episodes significantly expands the potential market for IGALMI® (dexmedetomidine) sublingual film. BioXcel Therapeutics, the developer of IGALMI®, previously estimated the market at 23 million annual episodes of bipolar or schizophrenia-related agitation occurring at home.1
This revised, higher estimate is based on several factors:
- Underestimation of previous data: The company believes that the earlier estimate of 23 million episodes, derived from historical claims data, likely underestimated the true frequency of agitation episodes. This is attributed to the lack of approved at-home treatment options, which may have led to underreporting of episodes.2
- New market research and clinical data: Recent market research indicates that patients experience approximately three agitation episodes per month in the home setting, a significant increase from the 1.2 episodes per patient per month suggested by older claims data.2 Furthermore, data collected from over 2,200 agitation episodes during the SERENITY At-Home pivotal Phase 3 trial has contributed to this updated understanding of episode frequency.3
IGALMI® is currently approved for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under the supervision of a healthcare provider.1 BioXcel Therapeutics is pursuing a supplemental New Drug Application (sNDA) to expand IGALMI®'s label for at-home use.1
The substantial increase in the estimated number of annual agitation episodes, from 23 million to 57-77 million, suggests a considerably larger total addressable market for IGALMI®, particularly for its potential use in the at-home setting. BioXcel Therapeutics views this expansion as a foundation for meaningful, long-term growth and value creation.2
