Sumatriptan/naproxen sodium: a review of its use in adult patients with migraine.

A fixed-dose combination of sumatriptan/naproxen sodium (Treximet(®)) has been approved in the US for the acute treatment of migraine in adults. In two randomized trials, sumatriptan/naproxen sodium demonstrated significantly better efficacy than sumatriptan alone, naproxen sodium alone, or placebo as late-intervention therapy for a single migraine episode in adults, as assessed by co-primary efficacy endpoints evaluating pain and other migraine-related symptoms, as well as health-related quality of life (HR-QOL) endpoints. In four other randomized trials, the drug combination was also effective as early intervention in adults with migraine (including those with menstrual migraine and dysmenorrhoea, or those with poor response or intolerance to triptan therapy) according to various pain-related primary efficacy and HR-QOL endpoints. Data from longer-term, non-randomized studies support these findings, and the drug combination appears to be beneficial in patients with migraine and cutaneous allodynia. In clinical trials, sumatriptan/naproxen sodium was generally well tolerated, with an overall tolerability profile similar to that of sumatriptan. The most common adverse events were in line with those expected for sumatriptan and naproxen sodium. Current data indicate that sumatriptan/naproxen sodium is a useful option in the treatment of adult migraine.