Publications

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Brandes JL et al. JAMA. 2007;297(13):1443-1454.

Two randomized, double-blind studies evaluated the efficacy and safety of a fixed-dose tablet of sumatriptan 85 mg and naproxen sodium 500 mg for acute migraine treatment. Conducted at 118 U.S. centers with 2,956 participants, the combination therapy was compared to sumatriptan alone, naproxen alone, and placebo. The combination tablet showed superior efficacy, with 65% and 57% of patients achieving headache relief at 2 hours versus 28% and 29% for placebo (P<.001). It also provided better relief from photophobia, phonophobia, and sustained pain. Adverse events were comparable to sumatriptan alone. The combination therapy was effective and well-tolerated.

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Lipton R et al. Cephalalgia. 2009;29:826-36.

Two crossover studies assessed consistency of response to sumatriptan/naproxen sodium 85/500 mg (S/NS) over four migraine attacks. Patients treated within 1 hour of mild pain onset. Co-primary endpoints were 2-hour pain-free response (2hPF) and 24-hour sustained pain-free response (24hSPF). In both studies, S/NS showed higher 2hPF rates (52% and 50% vs. placebo 25% and 20%) and 24hSPF rates (37% and 34% vs. placebo 17% and 12%, all P < 0.001). 2hPF occurred in over half of patients in the first three S/NS-treated attacks, and 24hSPF in over one-third. Adverse events were low and similar between S/NS and placebo.

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Mannix LK et al. Obstet Gynecol. 2009;114:106-13.  

Two randomized, double-blind, placebo-controlled trials assessed the efficacy and tolerability of a fixed-dose combination of sumatriptan 85 mg and naproxen sodium 500 mg in treating menstrual migraines associated with dysmenorrhea. Participants treated their migraines during the mild pain phase within one hour of onset. The combination was significantly superior to placebo for 2-hour pain-free response (42% vs. 23%, 52% vs. 22%; P<.001) and sustained pain-free response up to 24 hours. It also reduced the need for rescue medications and alleviated non-pain menstrual symptoms. No serious adverse events were reported; nausea and dizziness were the most common side effects.

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Mathew NT et al. Headache. 2009;49:971-982.

Two randomized, double-blind, placebo-controlled crossover trials evaluated the efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg and naproxen sodium 500 mg in migraineurs who had discontinued short-acting triptans due to poor response or intolerance. Patients treated within 1 hour of mild pain onset. Results showed sumatriptan/naproxen sodium was superior to placebo for sustained pain-free response from 2 to 24 hours (26% vs. 8% and 31% vs. 8%; P < .001) and for pain-free response at 2 hours (40% vs. 17% and 44% vs. 14%). Adverse events were mild, with chest discomfort reported in 2% of patients in one study. No serious adverse events were attributed to the study medication. Sumatriptan/naproxen sodium was well-tolerated and more effective than placebo for initial, intermediate, and sustained migraine relief.

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Silberstein S et al. Neurology. 2008;71:114-121. 

Two randomized, double-blind, placebo-controlled studies evaluated the efficacy and tolerability of a fixed-dose tablet of sumatriptan 85 mg and naproxen sodium 500 mg for early intervention in acute migraine. Participants treated a migraine within 1 hour of onset while pain was mild. Results showed that 52% and 51% of sumatriptan/naproxen-treated patients were pain-free at 2 hours, compared to 17% and 15% with placebo (p < .001). Significant pain-free responses were observed as early as 30 minutes and sustained up to 24 hours. Sumatriptan/naproxen also reduced traditional and nontraditional migraine symptoms. The most common adverse events were nausea (≤4%) and dizziness (≤2%). 

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Winner P et al. Mayo Clin Proc. 2007;82:61-68.

A 12-month open-label safety study assessed sumatriptan-naproxen sodium for moderate to severe acute migraines, including the safety of an optional second dose. Of 600 patients, 565 were treated, with 73% completing 6 months and 64% completing 12 months. Patients treated 5 migraines monthly with a median of 6 days between attacks. Most attacks (70%) were treated with one dose. Common adverse events included nausea, muscle tightness, and dizziness. Adverse events didn't increase with a second dose. Sumatriptan-naproxen sodium was well-tolerated, with no new findings or increased adverse events compared to individual components.

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