FDA approves Treximet (sumatriptan and naproxen sodium) formulation to treat migraine in children- Pernix Therapeutics

Pernix Therapeutics Holdings, Inc. a specialty pharmaceutical company, announced that the 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. 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 migraine, but treatment options have been limited, especially compared to adults.