The doses were 10 milligrams (mg) sumatriptan and 60 mg naproxen, 30/180 mg and 85/500 mg, respectively.
Between 23 percent and 29 percent of those who took one of the doses of sumatriptan/naproxen reported being pain-free within two hours of taking the drug, vs. 10 percent in the placebo group.
"This is a significant amount of people to be pain-free," said Rosen.
The 85/500 mg version of the drug showed greater benefit when taking into account pain relief and sensitivity to light and sound. Nausea rates, however, were no better than in the placebo group.
Participants receiving one of the other two doses of the drug combination had lower rates of nausea.
Rosen said that most previous studies looked at pain reduction only.
Side effects were minimal and the same in all groups.
The authors did state that the 10/60 mg combination may be the best choice for lower-weight adolescents with shorter-duration migraines, given that it was effective and reduced nausea.
Treximet was approved by the FDA for use in adults in 2008. It's unclear if GlaxoSmithKline will apply for a pediatric indication for the drug from the agency.
More information
The Cleveland Clinic has more on migraines in children and adolescents.
SOURCES: Ellen Drexler, M.D., associate director, neurology, Maimonides Medical Center, New York City; Noah Rosen, M.D., director, Headache Center, Cushing Neuroscience Institute, Great Neck, N.Y.; May 14, 2012, Pediatrics
| Copyright©2010 ScoutNews,LLC. All rights reserved |