BioXcel Therapeutics’ Igalmi (dexmedetomidine) Receives the US FDA’s Approval for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder
Shots:
- The approval was based on the (SERENITY I & II) studies evaluating Igalmi vs PBO in patients with agitation associated with schizophrenia & bipolar I or II disorder. The product is expected to be available in the US in Q2’22
- Both trials met its 1EPs & 2EPs i.e., both (120 & 180mcg) doses showed improvements from baseline along with a high response rate & demonstrated a rapid onset of action @20min. for both 180 & 120mcg doses in (SERENITY II) study while 20 & 30min. in (SERENITY I) study, respectively
- The results from the P-III (SERENITY II) trial in bipolar disorders were published in the JAMA. Igalmi can be self-administrated by patients under the supervision of a healthcare provider
Ref: Globe Newswire | Image: Bioxcel
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