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Sumatriptan Succinate and Naproxen Sodium Tablets (Treximet™)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; Assistant Clinical Professor of Medicine, University of California, San Francisco; Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Chan and Elliott report no financial relationship to this field of study.
A product containing a commonly used antimigraine drug (sumatriptan) and a NSAID (naproxen) has been approved for the treatment of acute migraine attacks. This fixed-dose combination is marketed by GlaxoSmithKline as Treximet™.
Sumatriptan-naproxen (SUM/NAP) is indicated for the acute treatment of migraine attacks with or without aura in adults.1
The recommended dose is 1 tablet and may be taken without regard to meals. No more than 2 tablets should be taken within 24 hours and should be at least 2 hours apart. The efficacy of a second dose has not been established.1
Each tablet contains sumatriptan 85 mg and naproxen sodium (500 mg) and they are supplied as compact containers of 9 tablets.
The combination provides two drugs with different mechanisms of action. SUM/NAP is more effective than sumatriptan monotherapy in terms of headache relief and pain free response at 2 hours post dosing, sustained (2 to 24-hour) headache relief and pain-free response, and less use of rescue medications.1,2
SUM/NAP is a fixed-dose combination and does not permit titration of either component.
Serious cardiovascular events have been reported with 5-HT1 agonists (triptans), and whether the addition of a NSAID, which carries its own cardiovascular risk, adds additional risk is not known.
The rationale of a sumatriptan/naproxen combination is to provide drugs with different mechanisms of action as well as different pharmacokinetics to treat an acute migraine headache. Sumatriptan is absorbed rapidly and the absorption of naproxen is delayed and along with its long elimination half-life contributes to sustained pain relief.2 In two identical studies (n = 2911) subjects were randomized to SUM/NAP, sumatriptan 85 mg, naproxen sodium 500 mg, or placebo. SUM/NAP was better than sumatriptan monotherapy in terms of 2-hour pain relief and sustained (2-24 hr) pain free response, and use of rescue medication.2 SUM/NAP was more effective than sumatriptan in terms of the absence of photophobia and phonophobia at 4 hours.2 Subjects reported returning to normal function earlier.3 There was no difference in terms of relief of nausea. While SUM/NAP was more effective than sumatriptan (85 mg) alone overall, it was no more effective than sumatriptan alone in subjects with severe migraine. Adverse events were similar between SUM/NAP and sumatriptan. In a 12-month, open-label study, 69% of attacks were treated with one dose and did not require a second dose and 28% of attacks were treated with a second dose that did not require other rescue medication.4 The estimated probability of patients taking a second dose or rescue medication is about 40% for sumatriptan alone.5 It is not known how SUM/NAP differs in effectiveness from sumatriptan and naproxen taken as two separate tablets. The wholesale cost of SUM-NAP is $18.37 per tablet compared to $15.67 for sumatriptan (100 mg) and $1.13 for a generic naproxen sodium (500 mg) tablet.
Migraine is a chronic, intermittently disabling condition. The prevalence of migraine is 18.2% among females and 6.5% among males.6 First line pharmacotherapies include NSAIDs, analgesic combinations, dihydroergotamine nasal spray, and triptans. The US Headache Consortium recommends NSAIDs and analgesic combinations for mild-to-moderate migraine attacks or severe migraine that have responded in the past.7 Triptans and dihydroergotamine nasal spray should be considered for moderate-to-severe attacks and in those that have responded poorly to NSAIDs or combination analgesics. Triptans are recommended for more severe attacks. SUM/NAP appears to provide an incremental and measurable improvement in acute and sustained headache relief compared to sumatriptan 85 mg monotherapy. It may be an alternative for patients with moderate-to-severe migraine who have not achieved adequate relief with a triptan alone.
1. Treximet Product Information. GlaxoSmithKline. April 2008.
2. Brandes JL, et al. JAMA. 2007;297:1443-1454.
3. Landy S, et al. MedGenMed. 2007;9(2):53.
4. Winner P, et al. Mayo Clin Proc. 2007;82(1):61-68.
5. Imitrex Product Information. GlaxoSmithKline. October 2007.
6. Lipton RB, et al. Headache. 2001;41:646-657.
7. Diamond M, Cady R. Am J Med. 2005;118(suppl 1):18S-27S.