BioXcel's Formulated Dexmedetomidine US Application For Agitation Under FDA Review

  • The FDA has accepted for reviewBioXcel Therapeutics Inc's 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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Posted In: NewsSmall CapFDAbipolar disorderBriefsSchizophrenia
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