FDA approves pediatric dosage of Treximet for acute migraine

The FDA recently approved Treximet for use in patients aged 12 years and older for the acute treatment of migraine with or without aura, according to the drug’s manufacturer.

A combination of sumatriptan and naproxen sodium, Treximet (Pernix Therapeutics) is the first approved combination prescription medicine for the treatment of acute migraine attacks in pediatric patients to contain sumatriptan. It is expected to provide more effective, sustained control of the pain and associated symptoms of migraine than either medicine alone.

“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,” Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic in Chicago and consultant to Pernix, said in a press release. “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.”

The FDA based its approval on a phase 3 safety and efficacy clinical trial — as well as long-term safety and pharmacokinetic data — demonstrating that Treximet was more effective than placebo in treating migraine in pediatric patients. Additionally, Treximet exhibited a favorable safety profile similar to that seen in adults.

The recommended pediatric dose is a single tablet consisting of 10 mg of sumatriptan and 60 mg of naproxen sodium per 24-hour period vs. the adult formulation which is one tablet containing 85 mg of sumatriptan and 500 mg of naproxen sodium.

“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,” Doug Drysdale, chairman and CEO of Pernix, said in the release. “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.”

Treximet also includes a boxed warning noting possible cardiovascular risks including thrombotic events, myocardial infarction, and stroke and gastrointestinal risks including bleeding, ulceration, and perforation of the stomach or intestines, according to a press release from the company.