Treximet (sumatriptan / naproxen sodium) has been approved by the Food and Drug Administration for the treatment of acute migraines in pediatric patients, the drug’s manufacturer, Pernix Therapeutics Holdings, announced in a statement.
Treximet has been available for the treatment of acute migraines (with or without aura) in adults since 2008, but is now available for use in children as young as 12 years.
The FDA approved Treximet after long-term safety and pharmacokinetic data, and the results of a phase III safety and efficacy clinical trial, demonstrated a safety profile similar to that of Treximet for adults. The recommended dose for pediatric patients (12 years and older) is a single tablet of Treximet 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per 24 hours; the maximum recommended dose is 85/500 mg per 24 hours.
“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 of the Diamond Headache Clinic, Chicago, and a 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.”