BioXcel Reports the US FDA’s Acceptance of BXCL501’s NDA for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

May 19, 2021 Auto Bot Acceptance, BioXcel, FDA, NDA, regulatory, Schizophrenia 0

Shots:

  • The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively
  • Results: BXCL501 met its 1EPs & 2EPs in both the studies, demonstrating rapid, and durable improvements from baseline across multiple agitation scales
  • The company is anticipating the PDUFA date as Jan 05, 2022. BXCL501 is investigational, orally dissolving thin film formulation of dexmedetomidine

Click here to­ read full press release/ article | Ref: GLOBE NEWSWIRE | Image: BioXcel

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