Glenmark Pharmaceuticals met its primary clinical endpoint in a Phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR). Ryaltris has been conditionally accepted as the brand name for GSP 301 Nasal Spray by the U.S. Food & Drug Administration (USFDA).
The company is planning to submit its first new drug application (NDA) to the USFDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018.
This Phase 3, U.S.-based trial was a three-arm, double-blind, randomized, parallel group, placebo-controlled safety study that enrolled 601 adults and adolescents 12 years of age and older with at least a two-year history of PAR. Patients were randomized to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. All trial arms used the same nasal spray delivery system. The study also assessed efficacy, as change from baseline in average morning patient-reported reflective Total Nasal Symptom Score (rTNSS), as a secondary endpoint.
Company Name | CMP |
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Sun Pharma Inds. | 1486.35 |
Dr. Reddys Lab | 5962.50 |
Cipla | 1400.00 |
Zydus Lifesciences | 933.40 |
Lupin | 1580.00 |
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