BioXcel's Formulated Dexmedetomidine US Application For Agitation Under FDA Review
- The FDA has accepted for review, BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application for BXCL501, an orally dissolving thin film formulation of dexmedetomidine.
- The application covers the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
- The agency's target action date is January 5, 2022.
- The FDA does not plan to hold an advisory committee meeting to discuss the application.
- Dexmedetomidine is a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms.
- Price Action: BTAI shares are up 1.4% at $32.2 during the premarket session on the last check Wednesday.
- Related content: Benzinga's Full FDA Calendar
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