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.
