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FDA Approves Treximet for Acute Migraine Treatment in Pediatric Patients

Source: Pain Medicine News

—PMN Staff

The FDA has approved Treximet (sumatriptan and naproxen sodium, Pernix) for the acute treatment of migraine with or without aura in patients aged 12 years and older.

Approximately 8% to 23% of all patients aged 11 years and older suffer from migraine, but treatment options are limited, according to Pernix.

“Until now, pediatric migraine sufferers have not had the same number of treatment options as 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, 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.”

Treximet was first approved in 2008 for the acute treatment of migraine with or without aura in adults. This latest approval was based on safety and efficacy data from three clinical trials that showed Treximet is significantly more effective than placebo for treating migraine in pediatric patients, and has a "favorable safety profile similar to that of Treximet for adults," according to Pernix.

Treximet has been shown to provide a "significantly greater percentage of adult patients with migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone."

The recommended dose for pediatric patients is a single tablet of Treximet (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour period. The maximum recommended dose per 24-hour period is 85/500 mg.

Treximet has a boxed warning noting cardiovascular and gastrointestinal risks.