NEW YORK (Reuters Health) – In a small preliminary study, a combination pill containing 85 milligrams of sumatriptan and 500 milligrams of naproxen sodium formulated in a rapid release technology was more effective than “usual therapy” at decreasing headache severity, lessening associated symptoms and attaining complete relief 2 hours after dosing.

The product, SumaRT/Nap (Treximet; GlaxoSmithKline, Pozen), was approved in 2008 by the US Food and Drug Administration based on regulatory studies that demonstrated it worked better than its individual components or placebo, the authors note in the May 17 online issue of Headache.

Dr. Roger Cady of the Headache Care Center, Springfield, Missouri and colleagues say they designed their study to go beyond regulatory studies and explore a more global definition of migraine relief beyond specific migraine-associated diagnostic symptoms.

Over 2 months, 135 adults treated their migraines with SumaRT/Nap. Their mean age was 44.3 years and they had suffered migraine headaches for more than 17 years, on average.

To measure their experiences with SumaRT/Nap compared to their usual migraine therapy (triptan(s) and/or other medication), subjects completed the Headache Impact Test, Revised Patient Perception of Migraine Questionnaire, and Completeness of Response Survey (CORS) at baseline and at 2 months.

In total, 636 migraine attacks were reported in first month of the study; 508 in the second month. Before SumaRT/Nap, the average migraine severity was rated as 1.59 on a scale of 0 to 3 for both months 1 and 2. With SumaRT/Nap, the headache severity rating fell significantly (P < 0.0001) to 0.53 in month 1 and 0.54 in month 2.

A comparison of diary records before SumaRT/Nap and 2 hours post-dosing showed an average 32% lessening of associated symptoms after treatment. An average of 60% of migraine attacks (691 of 1,144) resolved at 2 hours post-treatment and only about a third of attacks required a second dose (n = 376).

Based on the CORS responses at the end of the study, subjects rated SumaRT/Nap superior to their usual medications for complete migraine relief, quicker relief and longer-lasting relief. They also felt SumaRT/Nap was better than their usual medication in allowing them to function more normally, easing fatigue, relieving neck and shoulder pain.

They were also more confident that a single dose of medication would provide complete relief within 2 hours — that their migraine would not return within 2 hours. Overall satisfaction was also higher with SumaRT/Nap than with usual therapy.

“Compared to a subject’s usual treatment, SumaRT/Nap used early and consistently for treatment of acute migraine offers important clinical improvements, including lessening of associated symptoms beyond International Headache Society criteria,” the authors conclude.

Whether these findings are based on the pharmacological properties of SumaRT/Nap or a consistent early treatment approach can’t be determined from this study, the authors note.

Dr. Cady sponsored this research through a grant from GlaxoSmithKline. He and several co-authors have financial relationships with GlaxoSmithKline, Pozen, and other pharmaceutical companies. A complete list can be found with the original article.

Headache 2011.