Key clinical point: DFN-15- an oral, ready-made liquid solution of a selective cyclo-oxygenase-2 inhibitor celecoxib, was superior to placebo for acute treatment of a migraine attack of any pain intensity, along with a favorable safety and tolerability profile.
Major finding: Percentage of patients with freedom from pain (46.2% vs. 31.1%; P less than.001) and freedom from the most bothersome symptom (63.4% vs. 50.0%; P = .010) at 2 hours after dose was significantly higher for DFN-15 vs. placebo. No serious treatment-emergent adverse events or those leading to study drug termination were reported.
Study details: Data come from the second phase of a 2-phase, double-blind, multicenter trial, which re-randomized 535 patients with migraine to placebo or DFN-15 group.
Disclosures: This study was supported and funded by Dr. Reddy’s Laboratories group of companies, Princeton, NJ 08540, USA. The authors declared receiving funding, honoraria, and consulting from various sources. S Munjal reported being an employee and owning stocks and C Iaconangelo declared being a paid consultant of Dr. Reddy’s Laboratories.
Source: Lipton RB et al. J Pain Res. 2021 Feb 25. doi: 10.2147/JPR.S287571 .