Benzinga | May 19, 2021 08:11AM EDT

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