Positive headline results from the Vyepti RELIEF study for preventive migraine therapy.- Lundbeck

H. Lundbeck A/S announced headline results from the parallel group, double-blind, randomized, placebo-controlled RELIEF study that assessed the efficacy and tolerability of Vyepti (eptinezumab) when initiated during a migraine attack in patients who are candidates for preventive therapy. The study met statistical significance on the co-primary endpoints, demonstrating that patients receiving a 100 mg Vyepti infusion during a migraine attack achieved earlier time to freedom from headache pain and absence of their most bothersome symptom compared to patients receiving placebo. The most bothersome symptom was the individual patient’s choice between photophobia, phonophobia, and nausea.The key secondary endpoints of proportion of patients with pain freedom and proportion of patient with absence of their most bothersome symptom at 2 hours after the start of infusion, also met statistical significance. All other secondary endpoints were also statistically significant. Vyepti was well-tolerated as a preventive treatment when initiated during a migraine attack, consistent with the previous phase III studies with no new safety signals identified. The most common adverse reactions ( greater than 2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.