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Review
. 2024 Sep;31 Suppl 2(Suppl 2):e16434.
doi: 10.1111/ene.16434.

Sumatriptan-naproxen sodium in migraine: A review

Robyn-Jenia Wilcha  1 , Shazia K Afridi  2 , Piero Barbanti  3   4 , Hans Christoph Diener  5 , Tim Patrick Jürgens  6   7 , Michel Lanteri-Minet  8   9 , Christian Lucas  10 , Jerôme Mawet  11 , Xavier Moisset  12 , Antonio Russo  13 , Simona Sacco  14 , Alexandra J Sinclair  15   16 , Marja-Liisa Sumelahti  17 , Cristina Tassorelli  18   19 , Peter J Goadsby  1   20
Affiliations
Review

Sumatriptan-naproxen sodium in migraine: A review

Robyn-Jenia Wilcha et al. Eur J Neurol. 2024 Sep.

Abstract

Background: Varied responses to acute migraine medications have been observed, with over one-third (34.5%) of patients reporting insufficient headache relief. Sumatriptan-naproxen sodium, a single, fixed-dose combination tablet comprising sumatriptan 85 mg and naproxen sodium 500 mg, was developed with the rationale of targeting multiple putative mechanisms involved in the pathogenesis of migraine to optimise acute migraine care.

Methods: A narrative review of clinical trials investigating sumatriptan-naproxen sodium for both adults and adolescents was performed in March 2024.

Results: Across a total of 14 clinical trials in nine publications, sumatriptan-naproxen sodium offered greater efficacy for 2-h pain freedom (14/14) and sustained pain-free response up to 24 h (13/14) compared with monotherapy and/or placebo for both adult and adolescent study participants with an acceptable and well-tolerated adverse effect profile. Clinical trial data also demonstrates the effectiveness of sumatriptan-naproxen sodium in participants with allodynia, probable migraine, menstrual-related migraine and those with poor responses to acute, non-specific, migraine medication.

Conclusions: Multi-mechanistic therapeutic agents offer an opportunity to optimise acute medications by targeting multiple mediators involved in the pathogenesis of migraine. Sumatriptan-naproxen sodium resulted in greater initial and sustained pain freedom, compared with either sumatriptan, naproxen-sodium and/or placebo, for the treatment of single or multiple attacks of migraine across both adult and adolescent study populations.

Keywords: acute migraine attack; combination tablet; pharmacokinetics; sumatriptan‐naproxen sodium; treatment.

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Conflict of interest statement

R.W. reports no conflicts. T.P.J. has received speaker honoraria and/or honoraria as a consultant from AbbVie, Allergan, Grünenthal, Hormosan Pharma, Lilly, Lundbeck, Novartis, Orion Pharma, Pfizer, Sanofi and TEVA. A.R. has received speaker honoraria from Eli‐Lilly, AbbVie, Pfizer, Novartis and Teva and serves as Chief Editor of the Headache and Neurogenic Pain session of Frontiers in Neurology. A.J.S. reports personal fees from Invex therapeutics in her role as Director with stock holdings (2019–2023); other for advisory boards from Allergan, Novartis, Cheisi and Amgen outside the submitted work. P.J.G. reports, over the last 36 months, grants from Kallyope and personal fees from Aeon Biopharma, AbbVie, Aurene, CoolTech LLC, Dr Reddy's, Eli‐Lilly and Company, Linpharma, Lundbeck, Pfizer, PureTech Health LLC, Satsuma, Shiratronics, Teva Pharmaceuticals, Tremeau and Vial, and personal fees for advice through Gerson Lehrman Group, Guidepoint, SAI Med Partners, Vector Metric, and fees for educational materials from CME Outfitters and WebMD, and publishing royalties or fees from Massachusetts Medical Society, Oxford University Press, UptoDate and Wolters Kluwer, and a patent magnetic stimulation for headache (No. WO2016090333 A1) assigned to eNeura without fee. JM reports, over the last 36 months, speaker and/or consultant honoraria from Abbvie, Eli‐Lilly, Lundbeck, Orion, Pfizer, TEVA, as well as congress hospitality fees from Abbvie, Dr Reddy’s, GEP Sante, Lundbeck, Parexel and SOS oxygene.

Figures

FIGURE 1
FIGURE 1
Comparisons of combined sumatriptan‐naproxen sodium versus either drug alone were conducted as part of a Cochrane review published in 2016. All 14 of the separate analyses demonstrated that combined sumatriptan‐naproxen sodium was superior to monotherapy across all efficacy outcomes examined, including in the representative series shown here. The numerical additional effect of combined sumatriptan‐naproxen was larger versus naproxen sodium alone than for sumatriptan alone. (a) Comparison combined sumatriptan‐naproxen sodium versus sumatriptan alone, outcome pain‐free at 2 h; (b) comparison combined sumatriptan‐naproxen sodium versus naproxen alone, outcome pain‐free at 2 h; (c) comparison combined sumatriptan‐naproxen sodium versus sumatriptan alone, outcome 24‐h sustained pain free; and (d) comparison combined sumatriptan‐ naproxen sodium versus naproxen alone, outcome 24‐h sustained pain free. From Law and colleagues [30].
FIGURE 2
FIGURE 2
Responses to combination sumatriptan‐naproxen sodium in patients with a history of poor response to triptan monotherapy. (a) Twenty‐four‐hour sustained pain‐free response after dosing with sumatriptan‐naproxen sodium or placebo. (b) Pain‐free response 2 h after dosing with sumatriptan‐naproxen sodium or placebo. From Mathew and colleagues [26].
See this image and copyright information in PMC

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