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FDA Approves Treximet for Adolescents

Last month the U.S. Food and Drug Administration (FDA) approved Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.

Treximet is the first approved combination and first approved sumatriptan product for migraine patients ages 12 to 17. The two medications—sumatriptan and naproxen sodium—provide better control of pain and other migraine symptoms compared to either medicine taken alone.

Treximet has been approved for the acute treatment of migraine in adults since 2008, but it had not been approved for the younger age group, which had limited treatment options.

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said NHF board member Merle Diamond, MD, managing director of the Diamond Headache Clinic and a consultant to Pernix, the drug manufacturer.  “As many as 1 out of 5 teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school.”

The FDA’s approval of Treximet follows on the heels of its March approval of the migraine prevention medication Topamax (topiramate) for this same age group.

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