FDA Expands Ryaltris Nasal Spray Approval to Children Aged 6 to 11 Years with Seasonal Allergic Rhinitis
Key Insights
The FDA has expanded the indication for Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray to include pediatric patients aged 6 to under 12 years with seasonal allergic rhinitis (search).
The approval was supported by a phase 3 randomized, double-blind, placebo-controlled trial enrolling 446 pediatric patients aged 6–11 years, demonstrating greater nasal symptom improvement versus placebo.
Ryaltris is a fixed-dose combination of an antihistamine (665 µg olopatadine) and a corticosteroid (25 µg mometasone furoate), initially approved in 2022 for patients aged 12 and older.
The US Food and Drug Administration has expanded the indication for Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray to include pediatric patients aged 6 to younger than 12 years with seasonal allergic rhinitis (search), according to a press release from Glenmark Specialty S.A. (search) The product is now indicated for adults and pediatric patients aged 6 years and older, broadening the treatment landscape for younger children suffering from seasonal allergy symptoms.
The fixed-dose combination nasal spray, which contains the antihistamine olopatadine hydrochloride (665 µg) and the corticosteroid mometasone furoate (25 µg), was initially approved by the FDA in 2022 for the treatment of seasonal allergic rhinitis (search) symptoms in adults and pediatric patients aged 12 years and older.
Phase 3 Trial Supports Pediatric Expansion
The expanded approval was supported by data from a phase 3 randomized, double-blind, placebo-controlled clinical trial that enrolled 446 pediatric patients aged 6 to 11 years with seasonal allergic rhinitis (search). The study, published in Annals of Allergy, Asthma & Immunology, evaluated the efficacy and safety of one spray of Ryaltris in each nostril administered twice daily over a 14-day treatment period.
Patients who received Ryaltris demonstrated greater improvement in nasal symptoms compared to those who received placebo. Researchers also found that the treatment had a positive impact on patients' quality of life. The treatment was reported to be well tolerated during the study period.
Safety Profile and Monitoring Considerations
According to the prescribing information, the most common adverse reactions occurring in at least 1% of patients include dysgeusia, epistaxis, and nasal discomfort. The labeling also includes warnings and precautions regarding several potential risks, including epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, hypersensitivity reactions, immunosuppression and risk of infections, glaucoma and cataracts, hypercorticism and adrenal suppression, and somnolence.
Notably for the newly approved pediatric population, the prescribing information highlights the potential for reduced growth velocity in pediatric patients receiving corticosteroid-containing treatments and recommends routine growth monitoring during treatment.
Clinical Significance
Seasonal allergic rhinitis (search) affects a substantial number of school-aged children, and the availability of a fixed-dose combination nasal spray combining an antihistamine and a corticosteroid in a single formulation may offer a convenient treatment option. The twice-daily dosing regimen provides both antihistaminic and anti-inflammatory effects through a single delivery system, potentially improving adherence in the pediatric population.