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Wednesday, July 01, 2015
FDA Approved Nasal Spray to
The FDA recently approved a nasal spray to treat migraines in children. Please see the entire press release for more information.
Impax Specialty Pharma, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that the U.S. Food and Drug Administration (FDA) has approved ZOMIG Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.
ZOMIG Nasal Spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients. 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.
ZOMIG Nasal Spray's approval came after the FDA's review of safety and efficacy data from pivotal clinical trials demonstrating that ZOMIG Nasal Spray 5 mg 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. In clinical trials, the medication also had a safety profile similar to that demonstrated in adults. For full safety and efficacy information, please see the prescribing information.
The American Migraine Prevalence and Prevention (AMPP) Study estimated the 1-year prevalence of migraine among US children ages 12 to 19 at 6.3%, with prevalence among boys at 5.0% and among girls 7.7%.2 "Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine," said 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."
"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," said 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."
The recommended starting dose for ZOMIG Nasal Sprays in pediatric patients 12 years of age and older is 2.5 mg. As the individual response to ZOMIG Nasal Spray may vary, the dose should be adjusted on an individual basis. The maximum recommended single dose of ZOMIG is 5 mg. The maximum daily dose should not exceed 10 mg in any 24 hour period.
About ZOMIG Nasal Spray
ZOMIG Nasal Spray was first approved by the U.S. Food and Drug Administration (FDA) in September 2003for the acute treatment of migraine attacks, with or without aura, in adults. In clinical trials, ZOMIG Nasal Spray provided relief in as soon as 15 minutes for some patients and the maximum effect was reached within 2–4 hours for most adult patients. At 2 hours, 69% of patients taking the 5mg dose had headache response (taking the patient from moderate to severe pain to mild or no pain) and 36% were pain free.1