The US Food and Drug Administration (FDA) has approved zolmitriptan nasal spray (Zomig, Impax Specialty Pharma) for the acute treatment of migraine with or without aura in children 12 years of age and older, according to the company.
The spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients, the company states in a news release.
"Nasal sprays may offer an alternative method of administration when patients experience migraine-associated nausea, have difficulty taking oral formulations, or do not have liquids available," the company said.
The recommended starting dose of zolmitriptan nasal spray in children aged 12 years and older is 2.5 mg, with dose adjustments made on an individual basis, the company said. The maximum recommended single dose of zolmitriptan nasal spray is 5 mg. The maximum daily dose should not exceed 10 mg in any 24-hour period.
In clinical trials in children, zolmitriptan nasal spray 5 mg was significantly more effective than placebo in providing no headache pain and relief of headache and other associated symptoms of migraine, with a safety profile similar to that seen in adults, according to the company.
Zolmitriptan nasal spray was first approved by the US Food and Drug Administration in 2003 for acute treatment of migraine attacks in adults. In clinical trials in adults, zolmitriptan nasal spray provided relief in as soon as 15 minutes for some patients, and the maximum effect was reached within 2 to 4 hours for most patients. At 2 hours, 69% of patients taking the 5-mg dose had headache response (taking the patient from moderate to severe pain to mild or no pain), and 36% were pain free, the company notes.
The 1-year prevalence of migraine among US children aged 12 to 19 years is estimated at 6.3%, with higher prevalence in girls than boys (7.7% vs 5.0%)
"Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine. We are pleased that Zomig nasal spray has been approved by the FDA for use in patients ages 12 to 17," Alan M. Rapoport, MD, past president of the International Headache Society and clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, said in the news release.
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Cite this: Migraine: Zolmitriptan Nasal Spray Cleared for Kids 12 and Up - Medscape - Jun 17, 2015.