A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine With or Without Aura

Abstract

Background Safe, effective, oral therapies are needed for acute treatment of migraine. This clinical trial assessed the efficacy, tolerability, and safety of celecoxib oral solution (ELYXYB) in a single migraine attack associated with moderate-to-severe pain. Methods This Phase III, randomized, double-blind, placebo-controlled, multicenter trial treated adults with episodic migraine (with or without aura) with a single 4.8 mL dose of 120-mg celecoxib oral solution or placebo. Co-primary endpoints were the proportion of patients who were pain-free and free from the most bothersome migraine symptom (MBS) at 2 hours post-dose. The MBS was identified at screening from among nausea, photophobia, or phonophobia. Results Six hundred thirty-one patients were randomized (mean age 41 years, range 18–75; 84.3% female). One study site met prespecified outlier criteria and was excluded from efficacy analyses. This site had a mean 2-hour pain freedom placebo response rate of 75% vs 23.5% for all other sites. In subsequent analysis, 2-hour post-dose pain freedom response rates were significantly higher in the celecoxib oral solution group vs placebo (32.8%, [27.2%, 38.8%]) vs 23.5%, [18.5%, 29.2%]; P = 0.020). For 2-hour post-dose MBS freedom, response rates were significantly higher in the celecoxib oral solution group vs placebo (58.1% [51.4%, 64.5%] vs 43.9% [37.2%, 50.7%]; P = 0.003). A total of 10.7% (31/289) of patients treated with celecoxib oral solution and 9.9% (28/283) of placebo-treated patients reported a treatment-emergent adverse event (TEAE). Study drug-related TEAEs were reported by 7.3% (21/289) and 7.4% (21/283) of celecoxib oral solution and placebo patients, respectively; the most common were nausea (celecoxib oral solution: 1.4% [4/289] vs placebo: 1.8% [5/283]) and dysgeusia (celecoxib oral solution: 1.7% [5/289] vs placebo: 1.1% [3/283]). No serious TEAEs, deaths, or drug-related TEAEs leading to withdrawal were reported. Conclusions Celecoxib oral solution is a safe, effective COX-2-selective nonsteroidal anti-inflammatory drug for the treatment of acute migraine. In this analysis, celecoxib oral solution was significantly more effective than placebo and was also associated with a low rate of gastric TEAEs. Celecoxib oral solution may provide a convenient, alternate option to currently available treatments. Trial registration: ClinicalTrials.gov Identifier: NCT03009019; Registered January 4, 2017; Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03009019

Recent Advances and Updates in Trigeminal Autonomic Cephalalgias

“…The study with fremanezumab in episodic cluster headache was terminated early, as there was no significant difference between the treatment and placebo groups, albeit with an endpoint at only 4 weeks. 24 Galcanezumab is FDA-approved for the treatment of episodic cluster headache following the double-blind, randomized, placebo-controlled trial showing a reduced number of weekly cluster headache attacks when treated with galcanezumab. 5…”