BioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI® in the At-Home Setting

Core Insights - BioXcel Therapeutics is advancing its commercial planning for IGALMI, aiming for a supplemental New Drug Application (sNDA) submission this month for at-home use in treating agitation associated with bipolar disorders or schizophrenia [1][2] Company Developments - Mark Pavao has been appointed as Acting Chief Commercial Officer, bringing over 30 years of experience in CNS product commercialization to lead the development and execution of the company's commercial plans [1][2] - The company is focused on maximizing the value of the IGALMI franchise and improving patient access and convenience [2] Product Information - IGALMI (dexmedetomidine) is a sublingual film indicated for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults, with safety and effectiveness not studied beyond 24 hours from the first dose [3] - The product is administered under healthcare supervision, and its potential for at-home use addresses a significant unmet need in the treatment paradigm for these conditions [2][3] Market Positioning - The company aims to leverage strong clinical data and market feedback to position IGALMI as a unique treatment option, as there are currently no FDA-approved medicines for at-home use in this context [2] - Pavao's previous experience includes successful launches of multiple CNS therapies, which will be instrumental in the strategic planning for IGALMI's market entry [2]