Treatment with DFN-15, an oral liquid solution containing the selective cyclooxygenase-2 inhibitor celecoxib, was associated with greater pain relief of 2 hours and the most troublesome symptom (MBS) compared to placebo in patients with migraines. In addition, it was linked to greater improvements in headache and functional disability relief, according to study results published in the Journal of Pain Research.
A total of 531 adult patients (ages 18-75 years) with migraines of at least 1 year, including 2 to 8 seizures and no more than 14 headache days per month, were included in this double-blind study. In the first treatment period, participants were randomly assigned to either 120 mg DFN-15 or placebo to manage a single migraine attack of moderate to severe pain.
Study investigators randomly assigned 491 participants (mean age 41 years) to either DFN-15 (n = 243) or placebo (n = 248) to treat a bout of mild, moderate, or severe pain in the second treatment period .
At the start of the study, pain intensities were low in 17.2% (n = 85) of the patients, moderate in 58.4% (n = 288) of the patients and severe in 22.9% (n = 113) of the patients. Treatment with DFN-15 was compared to placebo after 2 hours in terms of freedom from pain (46.2% versus 31.1%; P ≤ 0.001) and MBS (63.4% versus 50.0%; P <0.001) think.
A proportionally lower rate of treatment-related adverse events (TEAEs) was observed in patients treated with DFN-15 (6.1%) than in patients treated with placebo (8.0%). The rate of drug-related TEAEs in the study was 4.5% in patients treated with DFN-15 and 5.6% in patients treated with placebo. The most common drug-related TEAEs in the study were nausea (1%) and dysgeusia (0.8%). There were no reports of Serious TEAEs, Severe TEAEs, or TEAEs that led to discontinuation of the study drug.
One limitation of this study was the re-randomization of patients to treat a second seizure, which may have increased the potential for carry-over effects.
The study’s researchers concluded that their results “indicated that DFN-15 was significantly more effective than placebo for the primary endpoints of first treated seizure, 2-hour pain relief, and 2-hour MBS-freedom”.
Disclosure: Several authors of the study have stated that they are part of the pharmaceutical industry. For a full list of the authors’ information, see the original 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