Treximet Approved by FDA for Treatment Acute Migraine in Children

Treximet, which is a combination of sumatriptan and naproxen sodium, was recently approved by the FDA for treatment of acute migraine in children aged 12 years and above.1 This makes it the first approved combination prescription medicine for migraine attacks in patients who are children, and the first approved treatment in this population that contains sumatriptan. Treximet has been approved for use in adults since 2008 in the US.

A pivotal phase III safety and efficacy clinical trial, in addition to a long-term safety and pharmacokinetic study, showed this combination to be significantly more effective in treating migraine in this particular population than placebo. It's important to note that the prescribing information for Treximet contains a boxed warning noting cardiovascular and gastrointestinal risks.

It's estimated that between 8% and 23% of all pediatric patients who are 11 years and older have migraines, but available options to treat this population are quite limited when compared to the adult population. It is hoped that the approval of Treximet in these patients will help meet this unmet medical need.

The updated prescribing information for Treximet, including the boxed warning, can be found here.

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