Brand‐Schieber, Elimor

Objective The objective of this study was to evaluate the efficacy, tolerability, and safety of 120 mg DFN‐15 vs placebo for the acute treatment of migraine. Background Certain nonsteroidal anti‐inflammatory drugs (NSAIDs) are guideline‐recommended therapies for the acute treatment of migraine, but patients who use them may have issues with gastrointestinal tolerability. Celecoxib, a selective inhibitor of cyclooxygenase‐2, produces analgesia similar to nonselective NSAIDs. DFN‐15 is an oral, ready‐made liquid solution of celecoxib being investigated for the acute treatment of migraine. Methods A randomized, double‐blind, placebo‐controlled, efficacy, tolerability, and safety study in adults with migraine was conducted. Subjects treated a single migraine attack with 120 mg DFN‐15 or placebo as soon as possible after the onset of pain of moderate to severe intensity. The 2 independent coprimary efficacy endpoints were the proportion of subjects with freedom from pain and the absence of the most bothersome symptom (MBS) at 2 hours postdose. A second double‐blind treatment period followed the first, but did not contribute to the primary outcomes and will be reported elsewhere. Results There were 622 subjects randomized (1:1) to double‐blind treatment with either 120 mg DFN‐15 or placebo, and 567 (91.2%) treated a migraine with study drug (n = 285 DFN‐15; n = 282 placebo). Groups were balanced in demographic characteristics; the mean age was 40, and most subjects were female (87% [494/567]). At 2 hours postdose, DFN‐15 was significantly superior to placebo for pain freedom (35.6% [98/275] vs 21.7% [57/263], P < .001), with an odds ratio (95% CI) of 2.00 (1.36, 2.94) and for freedom from the MBS (57.8% [134/232] vs 44.8% [104/232], P = .007), with an odds ratio (95% CI) of 1.68 (1.17, 2.43). A total of 13.3% (38/285) of DFN‐15‐treated subjects and 8.9% (25/282) of placebo‐treated subjects reported a treatment‐emergent adverse event (TEAE). Study drug‐related TEAEs were reported by 9.1% (26/285) of DFN‐15 subjects and 6.0% (17/282) of placebo subjects, the most common of which were dysgeusia (4.2% [12/285] vs 1.4% [4/282]) and nausea (3.2% [9/285] vs 1.8% [5/282]). No subjects treated with DFN‐15 reported TEAEs that were severe or led to withdrawal, and no serious TEAEs or deaths were reported in the study. Conclusions DFN‐15 was significantly more effective than placebo for the acute treatment of migraine, with a generally favorable tolerability and safety profile.