News

Treximet approved for pediatric acute migraines


 

References

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.”

mbock@frontlinemedcom.com

Recommended Reading

ED visits for tramadol misuse more than double over 5 years
MDedge Internal Medicine
Botox treatments improve urinary incontinence in neurogenic bladder dysfunction
MDedge Internal Medicine
Obesity implicated in spinal degeneration
MDedge Internal Medicine
AAN: Adjunctive perampanel reduces tonic-clonic seizures in refractory patients
MDedge Internal Medicine
AAN: Finding ways to improve door-to-needle times in stroke treatment
MDedge Internal Medicine
Prevalence of amyloid pathology differs across dementia type and age
MDedge Internal Medicine
Statins, fibrates lower stroke risk in elderly
MDedge Internal Medicine
Oral steroids modestly improve acute radiculopathy
MDedge Internal Medicine
SAEM: High-risk subtypes of delirium are easily missed
MDedge Internal Medicine
IHC: Real-world data support Botox in chronic migraine
MDedge Internal Medicine