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- BioXCel Therapeutics (BTAI -4.3%) said that a phase 3 trial of BXCL501 (sublingual dexmedetomidine) for agitation associated with bipolar disorder demonstrated statistically significant changes in primary and secondary endpoints.
- In the primary endpoint, both the 120 mcg and 180 mcg doses significantly reduced agitation compared with placebo as measured by change from baseline on the Positive and Negative Syndrome Scale-Excited Component ("PEC") total score two hours after treatment,.
- For the secondary endpoint, statistically significant treatment effects were first evident 20 minutes after initial treatment for both doses compared to placebo.
- Adverse events were 35.7% for sublingual dexmedetomidine 180 mcg, 34.9% for 120 mcg, and 17.5% for placebo.
- In December, the U.S. FDA extended the action date for BCXL501 to April 5, 2022.