Biohaven's BHV-0223 meets in Phase II/III for speaking anxiety

Biohaven Pharmaceuticals Holding Co. Ltd. (NYSE:BHVN) said BHV-0223 met the primary endpoint of reducing anxiety while performing an anxiety-provoking speech task vs. placebo in a U.S. Phase II/III trial to treat social anxiety disorder. The company plans to present additional data from the double-blind trial over the next year.

In the crossover trial, 35 mg oral BHV-0223 given one hour prior to each of two impromptu speech tasks significantly improved 21 patients’ anxiety on a 100-point visual analog scale (VAS) by 8.3 points compared with placebo (p=0.056). The protocol-specified significance level was p=0.1. In an analysis that measured change on the VAS from the prespeech baseline, BHV-0223 improved VAS scores by 14.4 points compared with placebo (p=0.0259)...