Pediatric migraine drug gets FDA green light

May 15, 2015

FDA has approved sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics) for the treatment of migraines in pediatric patients.

FDA has approved sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics) for the treatment of migraines in pediatric patients.

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A migraine is a type of headache may begin as a dull ache and then progress into a constant, throbbing pain, often accompanied by nausea and sensitivity to light or sound. Some people only have occasional migraines, but others have them every month for several days at time. An estimated 8% to 23% of pediatric patients aged 11 years and older suffer from migraines, but treatment options are limited for this population compared to adults, according to an FDA press release.

Treximet is the first approved combination medication for the treatment of acute migraine attacks in pediatric patients. The drug combines sumatriptan, a serotonin agonist that causes vasoconstriction and reduces inflammation, and naproxen, which has antipyretic, analgesic and anti-inflammatory properties. Together, these drugs provide more effective and sustained control of the pain and symptoms associated with migraines.

“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. “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.”

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FDA's approval of Treximet is based on review of a pivotal phase 3 safety and efficacy clinical trial, showing that Treximet is significantly more effective than placebo in treating migraines in pediatric patients. Long-term safety and pharmacokinetic data also demonstrated that Treximet in children has a favorable safety profile similar to that in adults.

The recommended dose of Treximet for pediatric patients aged 12 years of age and older is one 10/60 mg tablet (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour period with a maximum dose of 85/500 mg in a 24-hour period. Treximet carries a Boxed Warning for cardiovascular and gastrointestinal risks.

Read more: FDA drug approvals