FDA Approves Pediatric Migraine Medication

The U.S. Food and Drug Administration (FDA) has approved a drug to treat migraines in children.

The naproxen/sumatriptan (Treximet) combination was originally approved in April 2008.

“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,” Dr. Merle Lea Diamond, president and managing director of the Diamond Headache Clinic and consultant to Pernix, said in a statement. “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.”

The medication, made by Pernix Ireland, will be available in tablet form.

The drug comes with a boxed warning given the potential cardiovascular and gastrointestinal risks associated with taking it.

--Stephanie Vaccaro

References:

1. U.S. Food and Drug Administration. Drug details. www.fda.gov. Accessed May 18, 2015.

2. Pernix Therapeutics (PTX) receives FDA approval of TREXIMET as acute migraine treatment in pediatric patients [press release]. www.streetinsider.com. 2015 May 15.