The United States Food and Drug Administration has approved Impax Specialty Pharma's Zomig Nasal Spray for treatment of acute migraine with or without aura in pediatric patients who are 12 years and older.
Zomig nasal spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in paediatric 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 is a serotonin receptor agonist (Triptan) and also the first intra-nasal prescription medicine approved for acute migraine treatment in pediatric patients. The recommended starting dose for Zomig nasal sprays in paediatric patients aged 12 years 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.
The drug was approved after USFDA’s review of safety and efficacy data from clinical trials conducted by the sponsor. When compared to the placebo, Zomig Nasal Spray 5 mg significantly relieved headache and associated symptoms of migraine. The safety data of Zomig Nasal Spray in pediatric patients was similar to adults’ profile.
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