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Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.
Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.
Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).
Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.
Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8
Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.
Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.
Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).
Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.
Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8
Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.
Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.
Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).
Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.
Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8