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

by Vandana Singh, Benzinga Editor

May 19, 2021 8:11 AM | 1 min read | Make a Comment

The FDA has accepted for review, BioXcel 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.
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