BioXcel Therapeutics Inc. has named longtime biopharmaceutical executive Mark Pavao as its acting chief commercial officer, choosing an industry veteran to lead its efforts to expand the reach of its drug IGALMI.
The New Haven-based company said Monday that Pavao will lead its commercial strategy and launch planning as it prepares to seek federal approval to allow IGALMI to be used at home.
BioXcel said it plans to submit a supplemental New Drug Application, or sNDA, to the Food and Drug Administration (FDA) later this month. An sNDA asks the FDA to approve a new use for a drug that is already on the market.
IGALMI is approved for the short-term treatment of acute agitation in patients with bipolar disorder or schizophrenia in supervised healthcare settings. Acute agitation refers to sudden episodes of extreme restlessness, confusion or distress that can escalate quickly and often result in emergency care. The drug dissolves under the tongue or inside the cheek, allowing it to be absorbed without an injection.
Pavao has more than 30 years of U.S. and international commercial leadership experience, particularly with medicines that affect the central nervous system. His past work includes helping launch widely used psychiatric drugs such as Abilify, Paxil and Risperdal, as well as the migraine treatment Nurtec ODT.
More recently, he has advised emerging biotech companies on commercialization strategy.
BioXcel Chief Executive Officer Vimal Mehta said Pavao’s experience in launching and building brands for complex neurological and psychiatric medicines will be critical as the company evaluates how best to commercialize IGALMI and expand patient access.
If the FDA approves IGALMI for at-home use, it would become the first medication specifically cleared for treating acute agitation in people with bipolar disorder or schizophrenia outside of hospitals or clinics, the company said. Pavao said the lack of approved at-home options represents a significant unmet need and that IGALMI has the potential to change how agitation episodes are managed.
