FDA Approves Treximet for Pediatric Migraine

The therapy is approved for children 12 years and older with migraine with or without aura.

The FDA has approved Treximet, the first combination prescription medicine that contains sumatriptan, for pediatric patients 12 years and older with migraine.

The drug, which has an adult formulation, is manufactured by Pernix Therapeutics Holdings, Inc., and is a combination of sumtriptan and naproxen sodium that treats acute migraine attacks with or without aura. The drug was approved under priority review following a phase 3 safety and efficacy trial. 

“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 Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and consultant to Pernix. 

For pediatric patients 12 years of age and older, the recommended dose of Treximet is a single tablet (10.60 mg) per 24-hour period, with the maximum dose 85/500 mg per 24-hour period. The adult dose is one Treximet tablet 85/500 mg. 

“We are pleased with FDA’s decision and look forward to bringing migraine relief to pediatric patients by making the new Treximet dose available in the third quarter of this year,” said Doug Drysdale, chairman and CEO of Pernix.

Treximet is indicated for the acute treatment of migraine, and is not intended for use as prophylactic therapy for migraine or the management of hemiplegic and basilar migraine or cluster headache. Use of Treximet may increase the risk of serious cardiovascular events, myocardial infarction, and stroke, as well as gastrointestinal adverse events.