Pernix Therapeutics : FDA Oks TREXIMET For Use In Pediatric Patients

(RTTNews) - Pernix Therapeutics Holdings Inc. (PTX) announced that the U.S. Food and Drug Administration or FDA has approved TREXIMET or 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.

The recommended dose for pediatric patients 12 years of age and older is a single tablet of TREXIMET 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour period and the maximum recommended dose is 85/500 mg per 24-hour period. The recommended dose for adults is a single tablet of TREXIMET 85/500 mg.