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Mometasone Allergic Rhinitis Indication Expanded to Age 2 and Older

The U.S. Food and Drug Administration (FDA) has approved the expansion of the indication of mometasone furoate monohydrate (Nasonex) for the treatment of seasonal and perennial nasal allergy symptoms to include children 2 years of age and older. Mometasone is currently marketed for the treatment of symptoms of allergic rhinitis for adults and children age 3 and older.

“Corticosteroids sprayed into the nose are an effective drug intervention for nasal allergy symptoms. This expansion of the Nasonex indication for use in children as young as age 2 is an advance in the treatment of allergies in young children,” says Gary Rachelefsky MD, clinical professor at the University of California, Los Angeles, School of Medicine, in a news release. The decision follows the FDA’s review of a clinical trial designed to demonstrate the safety of mometasone in pediatric patients.

Fifty-six children aged 2 to 5 years with allergic rhinitis participated in a multiple-dose, randomized, third-party blind, parallel-treatment group, placebo-controlled study. Fifty-two children completed 42 consecutive days of treatment (100 mcg/day of mometasone) and the remaining 4 children completed 31 days of the same treatment.

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