Celecoxib, a cyclooxygenase-2 selective nonsteroidal anti-inflammatory drug, was found to be more effective than placebo at reducing acute migraine pain. These findings were published in the Journal of Pain Research.
The ELYXYB trial (ClinicalTrials.gov Identifier: NCT03009019) was a randomized, controlled, double-blind study conducted at 41 centers in the United States between 2016 and 2017. Patients (N=578) who were diagnosed with episodic migraine and had 2-8 monthly attacks were randomized in a 1:1 ratio to receive 120 mg/4.8 mL liquid celecoxib (25 mg/mL; n=289) or placebo (n=283). Over 10 weeks, study participants were instructed to take a dose within 1 hour of a non-recurrent, new attack and had the option to take a rescue medication. Patients kept a diary of migraine features and pain levels according to the Patient Perception of Migraine Questionnaire-Revised (PPMQ-R).
Participants had a mean age of 41.0 years (standard deviation [SD], 13.4), 84.3% were women, 73.7% were White, 56.2% had migraine with aura, and most patients experienced additional symptoms of photophobia (96.2%), worsening with movement (95.2%), phonophobia (87.9%), nausea (87.5%), and osmophobia (54.6%) during their migraine.
At 2-hours, the last observation carried forward (LOCF) was 32.9% for the celecoxib group and 25.8% for the placebo (P =.075) for freedom from pain and 58.9% and 45.0% (P =.003) for most bothersome migraine symptoms, respectively.
After removing data collected at an outlier site, the efficacy for freedom from pain at 2 hours was higher among the celecoxib recipients (LOCF, 32.8% vs 23.5%; P =.020) as was freedom from the most bothersome symptoms (LOCF, 58.1% vs 43.9%; P =.003). After 15 minutes, numerically more of the intervention recipients reported pain relief at all timepoints and by 1 hour, the difference was significant (P =.021). Headache relief was reported by 67.9% of celecoxib and 55.3% of placebo recipients at 2 hours.
The PPMQ-R scores were higher among the treatment recipients for efficacy (P =.003), function (=.007), medication effectiveness (=.002), and satisfaction (P =.010).
Stratified by additional migraine-associated symptoms, patients receiving celecoxib reported significantly greater relief from photophobia (P =.001) and phonophobia (P =.019) at 2 hours and nausea at 4 hours (P =.046).
Treatment-emergent adverse events were reported by 10.7% of celecoxib and 9.9% of placebo recipients, among whom 7.3% and 7.4% were drug-related, respectively. No drug-related events occurred among ³2.0% and the most common events were dysgeusia (1.7%) and nausea (1.4%) among the celecoxib cohort.
This study was limited by the fact that 1 of the treatment centers was determined to be an outlier and these data were removed from the final analysis.
The study authors concluded that celecoxib was safe and effective for the treatment of acute migraine and migraine-associated symptoms among patients with episodic migraine with or without aura.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Lipton RB, Munjal S, Tepper SJ, Iaconangelo C, Serrano D. 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. J Pain Res. 2021;14:2529-2542. doi:10.2147/JPR.S322292