Impax Labs : FDA Approves ZOMIG Nasal Spray For Migraine In Pediatric Patients

(RTTNews) - Impax Specialty Pharma, a division of Impax Laboratories Inc. (IPXL), announced that the U.S. Food and Drug Administration or 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 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.