Treatment with DFN-15, an oral, liquid solution comprising selective cyclo-oxygenase-2 inhibitor celecoxib, was associated with greater 2-hour freedom from pain and the most bothersome symptom (MBS) compared with placebo in patients with migraine. Additionally, it was linked to greater improvements in headache relief and functional disability, according to study results published in the Journal of Pain Research.

A total of 531 adult patients (age, 18-75 years) with at least a 1-year history of migraine, including 2 to 8 attacks and no more than 14 headache days per month, were enrolled in this double-blind trial. In the first treatment period, participants were randomly assigned to either 120 mg DFN-15 or placebo to treat a single migraine attack of moderate to severe pain.

The study investigators again randomly assigned 491 participants (mean age, 41 years) in the second treatment period to either DFN-15 (n=243) or placebo (n=248) to manage an attack of baseline mild, moderate, or severe pain intensity.


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At baseline, pain intensities were mild in 17.2% (n=85) of patients, moderate in 58.4% (n=288) of patients, and severe in 22.9% (n=113) of patients. Treatment with DFN-15 was superior to placebo at 2 hours in regard to freedom from pain (46.2% vs 31.1%, respectively; P ≤.001) and the MBS (63.4% vs 50.0%, respectively; P <.001).

A proportionally lower rate of treatment-emergent adverse events (TEAEs) was observed in patients treated with DFN-15 (6.1%) compared with patients assigned to placebo (8.0%). The rates of study drug-related TEAEs were 4.5% in patients treated with DFN-15 and 5.6% in patients treated with placebo. The most common study drug-related TEAEs were nausea (1%) and dysgeusia (0.8%). There were no reports of serious TEAEs, severe TEAEs, or TEAEs that led to termination of the study drug.

A limitation of this study was the re-randomization of patients to manage a second attack, which may have increased the potential of carry-over effects.

The study investigators concluded that their findings “showed that DFN-15 was significantly more effective than placebo for the primary endpoints for the first treated attack, 2-hour pain freedom and 2-hour MBS freedom.”

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

Reference

Lipton RB, Munjal S, Dodick DW, Tepper SJ, Serrano D, Iaconangelo C. Acute treatment of migraine with celecoxib oral solution: Results of a randomized, placebo-controlled clinical trial. Published online February 25, 2021. J Pain Res. doi:10.2147/JPR.S287571