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

Treximet is the first approved combination prescription medicine, and the first to contain sumatriptan, for the treatment of acute migraine attacks in pediatric patients. The two medicines – sumatriptan and naproxen sodium – in combination provide more effective, sustained control of the pain and associated symptoms of migraine compared to either medicine taken alone. Approval came after the FDA’s review of pivotal phase 3 safety and efficacy clinical trial, plus long-term safety and pharmacokinetic data, demonstrating 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.

Treximet carries a boxed warning noting cardiovascular and gastrointestinal risks. For full safety and efficacy information, please see the prescribing information. While Treximet has been approved for the acute treatment of migraine in adults since 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 eight percent to 23 percent of all pediatric patients 11 years and older suffer from migraine7, but treatment options have been limited, especially compared to adults.

For more details, go to: http://www.pernixtx.com/news/fda-approves-treximet-sumatriptan-and-naproxen-sodium-for-use-in-pediatric-patients/