The Food and Drug Administration (FDA) has approved Ryaltris (olopatadine hydrochloride, mometasone furoate) nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older.
Ryaltris is a metered, fixed-dose, prescription nasal spray that delivers 665mcg of olopatadine hydrochloride, an antihistamine, and 25mcg of mometasone furoate, a corticosteroid, in each spray. The approval was based on data from 2 randomized, double-blind, placebo- and active-controlled phase 3 studies (ClinicalTrials.gov Identifier: [Study 1] NCT02631551, [Study 2] NCT02870205) that evaluated the efficacy and safety of Ryaltris in a total of 2352 patients 12 years of age and older with seasonal allergic rhinitis.
Patients were randomly assigned to receive 1 of 4 treatments: Ryaltris, olopatadine hydrochloride nasal spray, mometasone furoate nasal spray, or placebo for 2 weeks. The primary endpoint for both studies was the change from baseline in average morning and evening patient-reported 12-hour reflective total nasal symptom score (rTNSS) over the 14-day treatment period.
Findings showed that treatment with Ryaltris resulted in statistically significant improvement in rTNSS compared with olopatadine hydrochloride, mometasone furoate, and placebo. However, a statistically significant difference was not observed when Ryaltris was compared with mometasone furoate in Study 1.
Both studies met key secondary endpoints demonstrating statistically significant improvement in the average morning and evening patient-reported 12-hour instantaneous total nasal symptom score and the reflective total ocular symptom score compared with placebo. The most common adverse reactions reported with Ryaltris were dysgeusia, epistaxis, and nasal discomfort.
Ryaltris is supplied in a bottle containing 240 metered sprays in addition to 6 initial priming sprays. The product will be marketed and distributed through Hikma Specialty USA Inc.
- Glenmark Specialty SA (Switzerland) receives NDA approval by the United States Food and Drug Administration (FDA) for Ryaltris™ nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older. News release. Glenmark Pharmaceuticals Limited. Accessed January 14, 2022. https://www.prnewswire.com/news-releases/glenmark-specialty-sa-switzerland-receives-nda-approval-by-the-united-states-food-and-drug-administration-fda-for-ryaltris-nasal-spray-for-the-treatment-of-symptoms-of-seasonal-allergic-rhinitis-in-adults-and-pediatric-pati-301461096.html
- Ryaltris. Package insert. Glenmark Specialty SA; 2021. Accessed January 19, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211746s000lbl.pdf