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FDA Approves Zolmitriptan (Zomig) Nasal Spray for Migraine in Pediatric Patients

First nasal-delivered drug for this indication

The FDA has given the nod to zolmitriptan (Zomig, Impax Pharmaceuticals) nasal spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. The product was first approved in September 2003 for the acute treatment of migraine attacks, with or without aura, in adults.

Zolmitriptan nasal spray is the first nasal-delivered prescription medication approved for the treatment of acute migraine attacks in pediatric 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, according to the manufacturer.

Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist (triptan).

The FDA’s approval came after a review of safety and efficacy data from pivotal clinical trials, which demonstrated that zolmitriptan nasal spray 5 mg was significantly more effective than placebo in providing no headache pain, the relief of headache, and other associated symptoms of migraine when treating migraine in pediatric 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 1-year prevalence of migraine among U.S. children aged 12 to 19 years at 6.3%, with the prevalence among boys and girls at 5.0% and 7.7%, respectively.

The recommended starting dose of zolmitriptan nasal spray in pediatric patients 12 years of age and older is 2.5 mg. As a patient’s individual response may vary, the dose should be adjusted on an individual basis. The maximum recommended single dose of zolmitriptan is 5 mg. The maximum daily dose should not exceed 10 mg in any 24-hour period.

In clinical trials, zolmitriptan nasal spray provided relief within 15 minutes for some patients, and the maximum effect was reached within 2 to 4 hours for most adult patients. At 2 hours, 69% of patients taking the 5-mg dose had a headache response (taking the patients from moderate or severe pain to mild or no pain), and 36% were pain-free.

The most common adverse events in adults in clinical trials of zolmitriptan nasal spray included unusual taste, paresthesia, hyperesthesia, and dizziness. The most common adverse event in pediatric patients (12 to 17 years of age) was unusual taste.

Sources: Impax Laboratories; June 16, 2015; and Zomig Prescribing Information; September 2013.


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