The United States Food and Drug Administration (FDA) has given its approval for zolmitripan nasal spray, or Zomig, for the treatment of migraines among kids between the ages of 12 and 17.
The nasal spray, which is manufactured by Impax Laboratories, Inc., is the "first nasal-delivered prescription medicine" for pediatric patients, who are likely to experience nausea due to migraine attacks and may not find any relief from oral medication, according to Medscape.
Zomig may be used for acute migraines with or without aura, or symptoms that may include neck sensations, seeing flashing lights, experiencing coordination and balance problems, before the onset of the actual headache. Dosage requirements start at 2.5 mg for 12-year-old children, but some adjustments may be made depending on the doctor's recommendation, to up to 5 mg. Dosage should not go beyond 10 mg during a 24-hour period.
Zolmitriptan nasal spray first received approval from the FDA back in 2003 for adults use only, but after several clinical trials, the medication was found to also provide relief among children, and to be as effective and safe as it is for adults.
Adolescent migraine is reportedly prevalent in at least 6.3 percent of children in America, as stated by the American Migraine Prevalence and Prevention (AMPP), according to CTV News, with kids between the ages of 12 to 19, at least 5 percent of boys and 7.7 percent of girls experience this debilitating headache, according to European Pharmaceutical Review.
"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 Fred Wilkinson, the President and Chief Executive Officer of Impax Laboratories in the reports. "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," Wilkinson added.
