The US Food and Drug Administration (FDA) has approved Impax Specialty Pharma's Zomig nasal spray for use in paediatric patients aged 12 years and above 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 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'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 paediatric patients. In clinical trials, the medication also had a safety profile similar to that demonstrated in adults.
 
The American Migraine Prevalence and Prevention (AMPP) study estimated the one-year prevalence of migraine among US children aged 12-19 years at 6.3 per cent, with prevalence among boys at 5 per cent and among girls 7.7 per cent.

"Until now, there have been few medications to treat paediatric patients with painful, debilitating attacks of migraine," said Dr Alan M Rapoport, former 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 aged 12 to 17 years."

"Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to paediatric 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 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.

Zomig nasal spray, a serotonin (5-HT)1B/1D receptor agonist (triptan), was first approved by the US Food and Drug Administration (FDA) in September 2003 for 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 per cent of patients taking the 5mg dose had headache response (taking the patient from moderate to severe pain to mild or no pain) and 36 per cent were pain free.