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Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.
Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.
Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.
Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.
Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389
Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.
Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.
Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.
Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.
Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389
Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.
Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.
Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.
Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.
Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389