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Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine

From the Jefferson Headache Center (S.D.S.), Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA; Headache Associates (L.K.M.), Cincinnati, OH; San Francisco Clinical Research Center and Headache Clinic (J.G.), CA; the University of Oklahoma Health Sciences Center (J.R.C.), Oklahoma City; and GlaxoSmithKline (S.C.B., M.H.A., S.A.M., S.E.L.), Research Triangle Park, NC.

Address correspondence and reprint requests to Dr. Stephen Silberstein, Jefferson Headache Center, 111 South 11th Street, Suite 8130, Philadelphia, PA 19107 stephen.silberstein{at}jefferson.edu

Background: Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome.

Objective: To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine.

Methods: Patients (aged 18 to 65 years) with International Headache Society–defined migraine with or without aura were enrolled in one of two identically designed, randomized, double-blind, parallel group, placebo-controlled studies. Patients treated a single migraine within 1 hour of onset of migraine head pain and while the pain was mild with either sumatriptan/naproxen or placebo. The primary efficacy measure was the percentage of patients who became pain-free 2 hours postdose.

Results: Intent-to-treat analyses consisted of 576 and 535 migraineurs. At 2 hours, 52% and 51% of sumatriptan/naproxen-treated patients were pain free, as compared to 17% and 15% of placebo-treated patients (p < 0.001). Significant pain-free responses in favor of sumatriptan/naproxen were demonstrated as early as 30 minutes, maintained at 1 hour, and sustained from 2 to 24 hours. At 2 and 4 hours, sumatriptan/naproxen provided significantly lower rates of traditional migraine-associated symptoms (nausea, photophobia, and phonophobia) and nontraditional migraine-associated symptoms (neck pain/discomfort and sinus pain/pressure). The most commonly reported adverse events were nausea (4%) and dizziness (2%).

Conclusion: The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.

Abbreviations: AE = adverse event; GI = gastrointestinal; ICHD = International Classification of Headache Disorders; IHS = International Headache Society; ITT = intent-to-treat; NSAID = nonsteroidal anti-inflammatory drug.

Sponsored by Pozen, Inc., and supported by GlaxoSmithKline, Research Triangle Park, NC.

Disclosure: Author disclosures are provided at the end of the article.

Received May 16, 2007. Accepted in final form March 17, 2008.