HAYWARD, Calif. — Impax Specialty Pharma’s Zomig Nasal Spray has been approved by the Food and Drug Administration for use in children ages 12 and older for the acute treatment of migraine.

Parent company Impax Laboratories Inc. said Tuesday that the product  is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients.

Zomig Nasal Spray (zolmitriptan 2.5 mg/5 mg) comes in a blue-colored, single-use plastic device with a gray protection cap, labeled to indicate the dose. The usual dose is a single nasal spray taken into one nostril, but Impax said the dose should be adjusted on an individual basis. The recommended starting dose for children 12 and older is 2.5 mg. The maximum recommended single dose is 5 mg, and the maximum daily dose shouldn’t exceed 10 mg in a 24-hour period.

Impax noted that nasal sprays may offer another method of administration when patients experience migraine-related nausea, have difficulty taking oral formulations or don’t have liquids available.

“Treatment options have been limited for pediatric patients, and we are pleased with FDA’s decision and look forward to bringing migraine relief to pediatric patients by making Zomig Nasal Spray available to this school-age patient population,” stated Fred Wilkinson, president and chief executive officer of Impax Laboratories. “This expanded indication exemplifies our strategy to broaden the reach of our current product portfolio to address unmet needs in underserved therapeutic areas, thereby adding value for patients and shareholders alike.”

Impax reported that the American Migraine Prevalence and Prevention Study estimated the one-year prevalence of migraine among U.S. children ages 12 to 19 at 6.3%, with prevalence among boys at 5% and among girls 7.7%.

“Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine,” according to Dr. Alan M. Rapoport, past president of the International Headache Society and Clinical Professor of Neurology at the David Geffen School of Medicine. “We are pleased that Zomig Nasal Spray has been approved by the FDA for use in patients ages 12 to 17.”