Children aged 12 to 17 years with migraines now have a new option for alleviating their symptoms.
Children aged 12 to 17 years with migraines now have a new option for alleviating their symptoms, as the FDA has approved Impax Laboratories’ intranasal zolmitriptan (Zomig Nasal Spray) for acute migraine attacks.
This nasal spray is the first prescription medicine of its kind to be approved for the acute treatment of migraine with or without aura in this age group, offering pediatric patients who have difficulty swallowing pills an alternative form of administration.
The FDA based its approval on data from clinical trials in which Zomig Nasal Spray 5 mg was significantly more effective than placebo in relieving headache pain and other associated symptoms when treating migraine in pediatric patients. The drug’s safety profile in this population was also comparable to the one demonstrated in adults.
“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 Impax President and CEO Fred Wilkinson in a press release. “This expanded indication exemplifies our strategy to broaden the reach of our current product portfolio to address unmet needs in underserved therapeutic areas.”
The recommended starting dose for Zomig Nasal Spray in patients aged 12 years and older is 2.5 mg, while the maximum recommended single dose is 5 mg. The daily dose of the drug should not exceed 10 mg in a 24-hour period.