Journal of Pain Research (Feb 2021)
Acute Treatment of Migraine with Celecoxib Oral Solution: Results of a Randomized, Placebo-Controlled Clinical Trial
Abstract
Richard B Lipton,1 Sagar Munjal,2 David W Dodick,3 Stewart J Tepper,4 Daniel Serrano,5 Charlie Iaconangelo5 1Neurology, Epidemiology and Population Health, and Psychologyand Behavioral Sciences Departments, Albert Einstein College of Medicine, Bronx, NY, USA; 2Clinical Development, Operations, and Medical Affairs, Dr. Reddy’s Laboratories, Princeton, NJ, USA; 3Neurology Department, Mayo Clinic, Scottsdale, AZ, USA; 4Neurology Department, Geisel School of Medicine at Dartmouth, Hanover, NH, USA; 5Biostatistics Department, Pharmerit Inc., Bethesda, MD, USACorrespondence: Sagar MunjalDr. Reddy’s Laboratories, 107 College Road East, Princeton, NJ, 8540, USATel +1 609-375 9900Email [email protected]: Nonsteroidal anti-inflammatory drugs are widely used for migraine, but gastrointestinal tolerability limits use. We previously reported results from the first treatment period of this 2-period, randomized, controlled study comparing DFN-15—an oral, ready-made liquid solution of a selective cyclo-oxygenase-2 inhibitor celecoxib—with placebo for the acute treatment of a moderate-severe migraine attack. Herein, we report the effects of treatment for the second treatment period.Methods: In the first treatment period of this trial, adults with migraine were randomized to double-blind trial treatment of attacks of moderate or severe pain with DFN-15,120 mg or placebo. For the second treatment period, reported herein, participants were re-randomized to treat an attack of any baseline pain intensity (mild, moderate, or severe). Co-primary efficacy endpoints specified for the first attack were not specified for the second attack.Results: Of the 531 patients who completed the first treatment period, 491 (n = 243 DFN-15; n = 248 placebo; 87% female, mean age 41 years) were re-randomized into the second double-blind treatment period. Baseline pain intensity was mild in 17.2% (85/493) of patients, moderate in 58.4% (288/493) of patients, and severe in 22.9% (113/493) of patients. At 2 hours post-dose, DFN-15 was superior to placebo for freedom from pain (46.2% [110/238] vs 31.1% [76/244], p ≤ 0.001) and the most bothersome symptom (63.4% [121/191] vs 50.0% [98/196], p = 0.010). Treatment-emergent adverse events (TEAEs) occurred in 7.1% (35/493) of patients (DFN-15: 6.1% [15/244]; placebo 8.0% [20/249]). Study drug-related TEAEs occurred in 5.1% (25/493) of patients (DFN-15: 4.5% [11/244]; placebo 5.6% [14/249]); nausea (1% [5/493]) and dysgeusia (0.8% [4/493]) were most common. No serious TEAEs, severe TEAEs, or TEAEs leading to study drug termination were reported.Conclusions: DFN-15 was superior to placebo for pain freedom and freedom from the most bothersome symptom when patients treat a migraine attack of any baseline pain intensity. Rates of TEAEs did not differ between treatment groups.Keywords: migraine, acute treatment, celecoxib, oral liquid
