Glenmark's Ryaltris meets in Phase III for perennial allergic rhinitis
Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported top-line data showing that twice-daily Ryaltris mometasone/olopatadine (formerly GSP 301) met the primary safety endpoint and a secondary efficacy endpoint in a Phase III trial to treat perennial allergic rhinitis.
The double-blind, U.S. trial enrolled 601 patients ages 12 and older with a two-year history of perennial allergic rhinitis. On the primary safety endpoint, Ryaltris for 52 weeks was well tolerated. The most common treatment-emergent adverse events reported were nosebleeds, headache and reduced taste sensitivity. On a secondary endpoint, Ryaltris significantly improved average morning patient-reported reflective Total Nasal Symptom Score (TNSS) from baseline over 52 weeks vs. placebo (p<0.0001)...
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