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news.Impax Specialty Pharma has received approval from the US Food and Drug Administration (FDA) for Zomig Nasal Spray for use in pediatric patients aged 12 years of age and older for the acute treatment of migraine with or without aura.
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The company said that Zomig is the first nasal-delivered prescription medicine approved to treat acute migraine attacks in pediatric patients.
The approval came after the FDA’s review of safety and efficacy data from pivotal clinical trials, which showed that Zomig Nasal Spray 5mg is significantly more effective than placebo in providing no headache pain, relief of headache, and other associated symptoms of migraine when treating migraine in pediatric patients.
The trials also showed that the medication had a safety profile similar to that demonstrated in adults.
David Geffen School of Medicine Clinical Professor of Neurology Dr Alan Rapoport said: "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."
The American Migraine Prevalence and Prevention (AMPP) Study estimated the one-year prevalence of migraine among US children aged 12 to 19 years at 6.3%, with prevalence among boys at 5% and among girls 7.7%.
The company noted that 2.5mg is the recommended starting dose for Zomig Nasal Sprays in pediatric patients 12 years of age and older, while the maximum recommended single dose of Zomig is 5mg.