Cerevel's Acute Anxiety Candidate Shows Encouraging Action In Healthy Volunteers
Cerevel Therapeutics Holdings Inc's (NASDAQ: CERE) 7.5 mg twice daily and the 25 mg twice-daily doses of darigabat demonstrated clinically meaningful and statistically significant anxiolytic activity in healthy volunteers compared with placebo.
After eight days of treatment, the darigabat 7.5 mg and 25 mg twice-daily doses demonstrated a 3.9 point and 4.5 point placebo-adjusted improvement, respectively, on the primary endpoint of the Panic Symptoms List (PSL-IV) total score.
The positive control alprazolam 1 mg twice-daily dose demonstrated a 1.6 point (p=0.286) placebo-adjusted improvement on the PSL-IV total score.
The secondary endpoint further supported these positive results, change in the Fear Visual Analog Scale (VAS Fear score), which demonstrated a 12.8 point (p=0.026), 7.8 point (p=0.282), and 0.9 point (p=0.876) placebo-adjusted improvement for the darigabat 7.5 mg, 25 mg, and alprazolam 1 mg twice-daily doses, respectively.
Darigabat was generally well-tolerated in this trial, with no serious adverse events and no treatment-related discontinuations in the darigabat cohorts.
Price Action: CERE shares are down 5.85% at $29.28 during the market session on the last check Tuesday.
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