Glenmark Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Ryaltris (olopatadine HCl, mometasone furoate) indicated for seasonal allergic rhinitis in patients aged ≥12 years.
Ryaltris is a nasal spray that contains olopatadine HCl 665mcg, an antihistamine, and mometasone furoate 25mcg, a steroid. The NDA included safety and efficacy data from 2 randomized, multicenter, double-blind, placebo-controlled trials in patients aged ≥12 years with seasonal allergic rhinitis (N=2352). Efficacy was based on patient-reported reflective total nasal symptom score (rTNSS) as well as other measures of nasal and ocular symptoms. For both studies, the use of Ryaltris led to statistically significant improvements in rTNSS vs placebo.
Data from a long-term, 3-arm, double-blind, randomized, parallel-group, placebo-controlled safety study (N=601) in patients with perennial allergic rhinitis was also included in the NDA. The study randomized patients to twice-daily Ryaltris or 2 other nasal spray formulations for 1 year. Efficacy was evaluated as a secondary endpoint, which was measured as change from baseline in average morning patient-reported rTNSS. The data showed a statistically significant and clinically meaningful improvement vs placebo (P<.0001) over the 1-year treatment period.
Loss of taste sensitivity, epistaxis, and nasal discomfort were the most commonly reported adverse reactions with Ryaltris.
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