Biohaven reports 'positive' results from Phase 2/3 study of vazegepant
Biohaven Pharmaceutical announced positive topline results from its randomized, dose ranging, placebo controlled, pivotal Phase 2/3 clinical trial evaluating the efficacy and tolerability of intranasal vazegepant 5, 10 and 20 mg versus placebo in 1,673 patients for the acute treatment of migraine. Vazegepant 10 and 20 mg was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours using a single dose. The benefits of vazegepant were durable and sustained without rescue medication through 48 hours, including: sustained pain freedom 2 to 24 hours; sustained pain freedom 2 to 48 hours; sustained pain relief 2 to 24 hours; and sustained pain relief 2 to 48 hours. Additional results from this study are anticipated to be presented at upcoming scientific meetings in 2020. Vazegepant was also superior to placebo on multiple secondary endpoints demonstrating early activity. Vazegepant had rapid onset with pain relief at 15 minutes, and return to normal function as early as 30 minutes. The 10 and 20 mg vazegepant doses showed therapeutic benefits on both pain relief and return to normal function at 2 hours. Intranasal vazegepant was well tolerated in this single dose trial. Individual adverse events greater than 5% were: dysgeusia and nasal discomfort. The majority of AEs were mild in intensity. There was no signal of hepatoxicity as no subjects had AST or ALT greater than 3x ULN, or total bilirubin greater than 2x ULN, in any treatment arm.