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

 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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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