FDA Approves Migraine Treatment for Teens


The FDA today approved sumatriptan and naproxen sodium to treat migraines in patients aged 12 to 17 years.

The FDA today approved sumatriptan and naproxen sodium (Treximet) to treat migraines in patients aged 12 to 17 years.

Pernix Therapeutics Holdings Inc’s Treximet can be used to treat migraines with or without aura. Pediatric patients can expect a typical dosage to be a single tablet containing 10 mg of sumatriptan and 60 mg of naproxen sodium. The maximum dose would mirror adults’ recommended dose of 85/500 mg per 24 hours.

In a press release, Pernix stated that Treximet is the first approved combination prescription medicine for migraines, and it is the first approved migraine treatment to include sumatriptan.

The FDA approval is based on a phase 3 clinical trial that demonstrated that Treximet is significantly more effective than placebo for the treatment of migraines among patients aged 12 to 17 years. The trial and safety data also confirmed that the drug has a similar safety profile as Treximet for adult patients.

Treximet was approved for adults back in 2008, and since then migraine treatment options have been relatively limited for pediatric patients, Pernix stated.

“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 and consultant to Pernix, said in a press release. “As many as 1 out of 5 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’s boxed warning cautions of cardiovascular and gastrointestinal risks.

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