Poster Number-47 - Impact of Celecoxib Oral Solution on Symptomatic Improvements in the Acute Treatment of Migraine

Impact of Celecoxib Oral Solution on Symptomatic Improvements in the Acute Treatment of Migraine

Nonsteroidal anti-inflammatory drugs (NSAIDs) have established efficacy and are commonly used in acute treatment of migraine headache as standard-of-care therapy. Many NSAIDS are associated with adverse gastrointestinal effects and slow absorption, illustrating the need for alternative acute treatments for migraine. Celecoxib oral solution (Elyxyb) is a selective cyclo-oxygenase (COX)-2 inhibitor in a well-tolerated and rapidly available formulation (T_max=42 min) that may improve gastrointestinal safety and tolerability while providing rapid effect onset. Two recently published phase 3 clinical trials have established the safety and efficacy of celecoxib oral solution (ClinicalTrials.gov identifiers: NCT03006276 and NCT03009019). Based on evidence from these trials, the US Food and Drug Administration has approved celecoxib oral solution for the acute treatment of migraine. Pooled analysis from the first treatment period of these 2 studies supported the efficacy and safety of celecoxib oral solution by achieving significance for the coprimary efficacy endpoints of freedom from pain and freedom from the most bothersome symptom (MBS) at 2 hours postdose with no safety concerns observed (see our these results in the abstract “Celecoxib Oral Solution in the Acute Treatment of Migraine: Pooled Efficacy and Safety Results From 2 Randomized Placebo-controlled Trials”). This pooled analysis evaluates secondary efficacy outcomes from 2 identical clinical trials comparing celecoxib oral solution and placebo for the acute treatment of migraine headache with or without aura.

Methods:

Participants reporting 2 to 8 migraine attacks per month of moderate to severe pain intensity were enrolled in these identical multicenter, randomized, double-blind, placebo-controlled clinical trials. The studies included more than 1200 total subjects at approximately 90 centers. Subjects were randomized (1:1) and administered either celecoxib oral solution (120 mg) or placebo within 1 hour of migraine onset. Participants recorded their responses to efficacy assessments in an eDiary. Secondary efficacy outcomes assessed at 2 hours postdose included the proportion of participants achieving headache pain relief and freedom from nausea, phonophobia, and photophobia. Only results pooled from the first double-blind period (DB1) were analyzed. Secondary outcomes from the pooled intent-to-treat full-analysis set population (n=1130) were tested for statistical significance using Fisher’s exact test. Odds ratios (ORs) with 95% confidence intervals (CIs) were also calculated.

Results:

Significantly more subjects administered celecoxib oral solution vs placebo reported 2-hour postdose headache pain relief (403 [71.3%] vs 317 [58.15%], respectively, p< 0.0001), freedom from predose phonophobia (238 [60.1%] vs 209 [50.6%], p=0.0072), and freedom from photophobia (283 [58.1%] vs 212 [43.4%], p< 0.0001) in this pooled analysis. Freedom from nausea and allodynia did not achieve significance 2 hours postdose. ORs (95% CI) comparing celecoxib oral solution and placebo were 1.8 (1.4-2.3) for headache pain relief, 1.5 (1.1-1.9) for freedom from phonophobia, and 1.8 (1.4-2.3) for freedom from photophobia. 

Conclusion:

This pooled analysis of 2 identical clinical trials revealed that administration of celecoxib oral solution helped significantly more patients to achieve key secondary efficacy endpoints at 2 hours postdose (during treatment period 1). These outcomes included headache pain relief, freedom from photophobia, and freedom from phonophobia. These secondary endpoint results support the co-primary efficacy endpoint results, where significantly more subjects achieved 2-hour postdose pain freedom and 2-hour postdose freedom from the MBS following administration of celecoxib oral solution, compared with placebo. The findings presented here provide additional evidence for the efficacy of celecoxib oral solution in the acute treatment of migraine headache in adults with or without aura.

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