The U.S. FDA this week approved Zomig Nasal Spray for the treatment of migraine with or without aura in pediatric patients aged 12 years and older. It is the first nasal spray approved for such use in pediatric patients.
Following the review of clinical trial data, the FDA concluded that Zomig Nasal Spray 5mg, a serotonin (5-HT)1B/1D receptor agonist, is safe and effective. In the trials, the drug showed a similar safety profile in young patients as it did in adults, and Zomig Nasal Spray 5mg was shown to be significantly more effective than placebo in providing no headache pain, relief of headache, and other symptoms associated with migraine.
“Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine,” Alan M. Rapoport, MD, 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.”
Fred Wilkinson, president and chief executive officer of Impax Laboratories, added, “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.”
The recommended starting dose for pediatric patients 12 years and older is 2.5mg, however, based on individual patient response, dosing can be increased to a maximum of 5mg. The maximum daily dose should not exceed 10mg in a 24-hour period.