The US Food and Drug Administration has expanded the indication for olopatadine hydrochloride and mometasone furoate (RYALTRIS) nasal spray to include pediatric patients aged 6 to younger than 12 years with seasonal allergic rhinitis, according to a press release from Glenmark Specialty S.A. The labeling now includes adults and pediatric patients aged 6 years and older.

The approval was supported by a phase 3 randomized, double-blind, placebo-controlled trial that enrolled 446 pediatric patients aged 6 to 11 years with seasonal allergic rhinitis. During the 14-day treatment period, patients who received olopatadine hydrochloride and mometasone furoate nasal spray had greater improvement in nasal symptoms compared to patients who received placebo. The treatment was reported to be well tolerated during the study period.

Olopatadine hydrochloride and mometasone furoate are a fixed-dose combination nasal spray containing a histamine-1 receptor inhibitor and a corticosteroid. The product received its initial US Food and Drug Administration approval in 2022 for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients aged 12 years and older. With the expanded indication, the product is now indicated for adults and pediatric patients aged 6 years and older.

According to the prescribing information included in the announcement, the most common adverse reactions occurring in at least 1% of patients are dysgeusia, epistaxis, and nasal discomfort. The prescribing information also includes warnings and precautions regarding epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, hypersensitivity reactions, immunosuppression and risk of infections, glaucoma and cataracts, hypercorticism and adrenal suppression, somnolence, and the potential for reduced growth velocity in pediatric patients receiving treatment. The prescribing information recommends routine growth monitoring during treatment.

Source: Glenmark Specialty S.A.