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.