FDA Approves Zomig Nasal Spray for Migraine for Ages 12 and Up

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The agency approved Zomig (zolmitriptan) Nasal Spray for use in pediatric patients aged at least 12 years.

Impax announced that the Food and Drug Administration (FDA) has approved Zomig (zolmitriptan) Nasal Spray for use in pediatric patients aged ≥12 years for the acute treatment of migraine with or without aura.

The approval was based on safety and efficacy data from clinical trials, which demonstrated that Zomig Nasal Spray 5 mg was significantly more effective in providing no headache pain, relief of headache, and other associated symptoms of migraine when treating migraine in pediatric patients compared to placebo.

Zomig Nasal Spray, a selective 5-HT1B/1D receptor agonist, is already indicated for the acute treatment of migraine with or without aura in adults. It is available in 2.5-mg and 5-mg single-use nasal spray units.

For more information visit Zomig.com.

This article originally appeared on MPR