Sumatriptan/naproxen sodium combination for the treatment of migraine

Abstract

Sumatriptan 85 mg with naproxen sodium 500 mg, a combination tablet for the acute treatment of migraine, is approved in the USA. It is likely that triptan/NSAID combination benefits are a class effect, although the majority of data are on sumatriptan and naproxen sodium. The combination tablet demonstrated superior effectiveness over its individual components or placebo in two Phase III regulatory trials on six coprimary end points. The pharmacokinetic shifts in the combination tablet result in an earlier T_max for sumatriptan, a later T_max for naproxen sodium and a reduction of the C_max by 36% for naproxen sodium compared with the components alone. In addition, the 85 mg dose of sumatriptan in the combination tablet has an area under the curve similar to 100 mg of sumatriptan alone. The clinical advantage of the sumatriptan and naproxen sodium combination is likely to be prolonged benefit per attack, that is, a sustained pain-free response.

Keywords::

• migraine
• naproxen sodium
• NSAID
• sumatriptan
• triptan

Financial & competing interests disclosure

Catalina Cleves has no financial or conflict of information to disclose.

Stewart J Tepper has received grants/research support from: Allergan, Alexza, ANS/Advanced Bionics, AstraZeneca, Eisai, Endo, Forrest, GSK, King, Merck, Medtronix, Minster, Neurochem, NMT, Novartis, Nupathe, OrthoMcNeil, Pfizer, Pozen, Proethic, Takeda, Winston, Vernalis.

Stewart J Tepper has also acted as a consultant in last 5 years (only those marked 2007–2008 are current) for: Allergan (2007), AstraZeneca, Coherex (2008), Elan, Endo (2007), Forrest, GSK (2007), Merck (2007), NMT (2007), Nupathe (2008), OrthoMcNeil (2007), Vernalis. He is on the Speakers’ Bureau (only those marked 2007–2008 are current) for: Allergan, AstraZeneca, Endo (2007), GSK (2008), Merck (2008), NMT (2008), OrthoMcNeil (2007), Pfizer, Valeant (2008). Stewart J Tepper is also on the Advisory Board for GSK, Merck.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this drug profile manuscript.