FDA Approves TREXIMET® for Use in Pediatric Patients

Industry News

Pernix Therapeutics Holdings, a pharmaceutical company based in Morristown, NJ announced that the FDA has approved TREXIMET for the treatment of migraine with or without aura in pediatric patients 12 years of age or older.  TREXIMET is a combination medicine containing sumatriptan, a serotonin receptor agonist and naproxen, a non-steroidal anti-inflammatory drug.  Clinical trials have shown that this combination of two medicines provides greater pain relief in migraine patients compared to either medicine taken alone.  The FDA first approved TREXIMET in 2008 for the acute treatment of migraine attacks in adults.  And this approval for pediatric use came after the review of a phase III clinical trial 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.


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