The U.S. Food and Drug Administration (FDA) has approved Pernix Therapeutics Holdings’ 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 prescription medicine, and the first to contain sumatriptan, for the treatment of acute migraine attacks in pediatric patients. The two medicines—sumatriptan and naproxen sodium—in combination provide more effective, sustained control of the pain and associated symptoms of migraine compared to either medicine taken alone.

Approval came after the FDA’s review of pivotal phase 3 safety and efficacy clinical trial, plus long-term safety and pharmacokinetic data, demonstrating that Treximet is significantly more effective than placebo in treating migraine in pediatric patients and has a favorable safety profile similar to that of TREXIMET for adults.

“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, M.D., president and managing director of the Diamond Headache Clinic and consultant to Pernix. “As many as one out of five 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.”

“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 chief executive officer, Pernix. “This expanded indication exemplifies our strategy to expand the reach of our current product portfolio to address additional underserved therapeutic areas, thereby adding value for patients and shareholders alike.”

The recommended dose for pediatric patients 12 years of age and older is a single tablet of Treximet 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour period and the maximum recommended dose is 85/500 mg per 24-hour period.1 The recommended dose for adults is a single tablet of Treximet 85/500 mg.