Pediatric Migraine Rx Gets FDA OK

Treximet (sumatriptan and naproxen sodium), from Pernix Therapeutics, approved to treat migraines in teens

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) today approved a combination medication to treat migraines in teens.

This Pernix Therapeutics drug is called Treximet (sumatriptan and naproxen sodium), and it adds to the somewhat limited treatment options for young migraine patients.

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and consultant to Pernix, in a press release. “As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school.”

Migraines are intense headaches that often come with disturbed vision and light sensitivity. The FDA approved Treximet to treat migraines in patients older than 12 after clinical trials and data suggested that the Pernix drug was both safe and effective.

Although the FDA gave Treximet its stamp of approval, it did include a boxed warning. This warning notes raised cardiovascular and gastrointestinal risks with Treximet use. These risks include heart attacks, blood clots, stroke, stomach bleeding and ulcers.

Review Date: 
May 15, 2015
Last Updated:
May 19, 2015