Trial Results Indicate Potential for Celecoxib in the Acute Treatment of Migraine Pain

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An oral solution of celecoxib, a selective inhibitor of cyclo-oxygenase 2, is superior to placebo for the acute treatment of migraine pain.

An oral solution of celecoxib (DFN-15), a selective inhibitor of cyclo-oxygenase 2, is superior to placebo for the acute treatment of migraine pain, a study in Headache reports.

In this randomized, double-blind trial, adult patients with migraine (87% women) were randomly assigned to receive 120 mg DFN-15 (n=285) or a matching placebo (n=282) for the treatment of a new single migraine attack. Treatment was administered as soon as possible after the onset of moderate to severe pain.

At 2 hours after treatment, researchers examined the proportion of patients with pain freedom and the absence of the most bothersome symptom. In addition, the researchers assessed the change in the functional disability score, treatment satisfaction, and the proportion of patients free from nausea, photophobia, and phonophobia at several points.

Treatment with DFN-15 was associated with a significantly greater reduction in pain freedom at 2 hours than seen with placebo (35.6% vs 21.7%, respectively; odds ratio [OR], 2.00; 95% CI, 1.36-2.94; P <.001). A greater proportion of patients in the DFN-15 group was also free from the most bothersome symptom at 2 hours (57.8% vs 44.8%, respectively; OR, 1.68; 95% CI, 1.17-2.43; P =.007).

The proportion of patients reporting a treatment-emergent adverse event (TEAE) was 13.3% in the DFN-15 group vs 8.9% in the placebo group. In addition, 9.1% of DFN-15-treated patients and 6.0% of placebo-treated patients experienced a study drug-related TEAE. None of the TEAEs associated with DFN-15 led to study withdrawal, and none of the TEAEs was serious or associated with mortality.

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A limitation of the study was the lack of assessment of the study drug during mild pain or during multiple migraine attacks.

Despite these limitations, these findings suggest “DFN-15 has the potential to become a reliable and convenient acute therapeutic option for patients with migraine,” the authors wrote.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Lipton RB, Munjal S, Brand-Schieber E, Tepper SJ, Dodick DW. Efficacy, tolerability, and safety of DFN-15 (celecoxib oral solution, 25 mg/mL) in the acute treatment of episodic migraine: a randomized, double-blind, placebo-controlled study [published online October 24, 2019]. Headache. doi:10.1111/head