Efficacy of Celecoxib Oral Solution in Adults With and Without Baseline Nausea: Post Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials in the Acute Treatment of Migraine
Stewart Tepper1, Daniel Serrano2, Mancia Ko3, Richard Lipton4, Todd Kunkel3
1Geisel School of Medicine At Dartmouth, 2OPEN Health group, 3Collegium Pharmaceutical, 4Albert Einstein College of Medicine
Objective:

To compare the efficacy of celecoxib oral solution 120 mg with placebo in the acute treatment of migraine attacks with and without baseline nausea.

Background:

Celecoxib oral solution (Elyxyb) is a liquid formulation of the cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine in adults. NSAIDs are thought to exacerbate nausea.

Design/Methods:
Post-hoc analysis of pooled data from 2 randomized, double-blind, placebo-controlled trials; adults treated 1 moderate-severe migraine attack with celecoxib oral solution 120 mg/4.8 mL or placebo. Efficacy endpoints were pain freedom, freedom from most bothersome symptom (MBS), and pain relief at 2 hours postdose. The population was stratified by the presence or absence of nausea at baseline. Regression models compared efficacy in the subgroups (with vs. without baseline nausea) using a treatment-by-nausea interaction. A regression model evaluated treatment-emergent nausea at 2 hours postdose in subjects without baseline nausea.
Results:

Among 214 participants, baseline nausea was similar in the celecoxib oral solution and placebo treatment groups (20.2% vs 19.6%). At 2 hours postdose, celecoxib oral solution 120 mg was superior to placebo for pain freedom in subjects with baseline nausea (22% vs 15%, p<0.001) and without baseline nausea (37% vs 25%, p<0.001); MBS freedom in subjects with baseline nausea (53% vs 40%, p<0.001) and without baseline nausea (59% vs 44%, p<0.001); and pain relief in subjects with baseline nausea (63% vs 51%, p<0.001) and without baseline nausea (74%% vs 60%, p<0.001). Among subjects without baseline nausea, treatment-emergent nausea at 2 hours postdose was more common with placebo than celecoxib oral solution, but the difference was not statistically significant (32.3% vs 23.7%, p=0.065).

Conclusions:

Celecoxib oral solution 120 mg was more effective than placebo for pain freedom, MBS freedom, and pain relief at 2 hours postdose in subjects with or without baseline nausea. Celecoxib oral solution did not cause treatment-emergent nausea.

10.1212/WNL.0000000000202237