What do we already know about this topic?

• NSAIDs (nonsteroidal anti-inflammatory drugs) inhibit prostaglandin synthesis by blocking two cyclooxygenase isoforms, COX-1 and COX-2.
• The efficacy of celecoxib, a selective COX-2 inhibitor, as an acute treatment for episodic migraine has not been established.

How was this study conducted?

• Two identical Phase III randomized, double-blind, placebo-controlled, multicenter studies on patients (aged 18–75 years) with episodic migraine (n=631 and n=622) were conducted.
• Patients were randomized 1:1 to DFN-15 (Celecoxib Oral Solution, 25 mg/ml, the total dose was 120 mg/ml) or matching placebo to treat a migraine with moderate-to-severe headache.
• The co-primary endpoints were the proportion of subjects with pain freedom (moderate or severe pain at baseline goes to no-pain 2 hours post-dose) and freedom from the most bothersome symptom (MBS) at 2 hours post-dose in the first double-blind period.
• Subjects were re-randomized into a second double-blind period and dosed at any pain level.