Pernix’s Treximet for Children With Migraines Wins FDA Nod

May 21, 2015

New Jersey-based Pernix Therapeutics plans to make a lower dose of its Treximet migraine medication available to children in the third quarter of this year, following FDA approval last week.

The agency greenlighted the new 10/60 mg dosage for pediatric patients ages 12 and older who experience migraines with and without aura.

Treximet (sumatriptan and naproxen sodium) is the first approved combination medication, and the first sumatriptan product, to treat acute migraine attacks in children, the company says. Sumatriptan is in a class of drugs that narrow blood vessels in the brain to relieve swelling. Naproxen is a nonsteroidal anti-inflammatory drug.

The pediatric combination was approved based on results of a Phase III safety and efficacy trial proving the combination better at controlling pain and treating associated symptoms in children than placebo.

Treximet was approved in 85/500 mg dose form for adults in 2008. — Lena Freund