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Pernix’s Treximet gets FDA approval to treat migraine in pediatric patients

Pernix Therapeutics Holdings has received approval from the US Food and Drug Administration (FDA) for Treximet (sumatriptan and naproxen sodium) for use in pediatric patients aged 12 years and older to treat migraine with or without aura.

The approval marks the first approved combination and first approved sumatriptan migraine product for patients aged 12-17 years.

The company said that the two medicines sumatriptan and naproxen sodium in combination offer more effective, sustained control of the pain and associated symptoms of migraine compared to either medicine taken alone.

The approval was based on pivotal phase III safety and efficacy clinical trial, plus long-term safety and pharmacokinetic data.

Data showed 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.

Pernix consultant and Diamond Headache Clinic president and managing director Merle Lea Diamond said: "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.

"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."

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

Pernix chairman and CEO Doug Drysdale said: "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.

"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."