FDA Okays Sumatriptan/Naproxen (Treximet) for Migraine in Teens

Pauline Anderson

Disclosures

May 15, 2015

The US Food and Drug Administration (FDA) has approved a combination of sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics Holdings Inc) for the acute treatment of migraine with or without aura in pediatric patients 12 years of age and older, the company announced today.

The product is the first approved combination prescription medicine, and the first to contain sumatriptan, for the treatment of acute migraine attacks in pediatric patients, a release from the company notes. The combination of sumatriptan and naproxen sodium provides more effective, sustained control of pain and associated symptoms of migraine compared with either medicine taken alone, the release 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," Merle Lea Diamond, MD, president and managing director, Diamond Headache Clinic, and consultant to Pernix, commented in the statement.

"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 treatment contributes to the relief of migraine through pharmacologically different mechanisms of action, the release notes. Sumatriptan is a selective 5-hydroxytryptamine1 20 (5-HT1) receptor subtype agonist that mediates vasoconstriction of the human basilar artery and vasculature of human dura mater. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs, which inhibits the synthesis of inflammatory mediators.

The recommended dose for children 12 years of age and older is a single tablet of Treximet 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per day, with the maximum recommended dose being 85/500 mg per day. The recommended dose for adults is a single tablet of 85/500 mg.

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

While the product was approved for the acute treatment of migraine in adults in 2008, the FDA set a priority review of the supplemental New Drug Application based, in part, on the need for options among this specialty population. An estimated 8% to 23% of all pediatric patients 11 years and older have migraine, but treatment options have been limited, especially compared to adults.

Boxed Warning

Treximet carries a boxed warning noting cardiovascular and gastrointestinal risks.

According to this warning, the drug may cause an increased risk for serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use.

Serious gastrointestinal adverse events may include bleeding, ulceration, and perforation of the stomach or intestines, with elderly patients being at greater risk for serious gastrointestinal events.

The new pediatric dose should be available in the third quarter of this year, Doug Drysdale, chairman and chief executive officer, Pernix, said in the company release.

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