Glenmark Pharmaceuticals has reported a positive results for GSP 301, an investigational fixed-dose combination of mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg) administered twice-daily as a nasal spray being studied for the treatment of seasonal allergic rhinitis. These results are from a recently completed Phase 3 trial assessing the efficacy and safety of GSP 301 combination therapy versus mometasone, olopatadine or placebo.
This Phase 3, U.S.-based trial was a four-arm, double-blind, randomized, parallel group, active and placebo-controlled study that enrolled 1,176 adults and adolescents 12 years of age and older for 14-days of twice daily treatment with GSP 301, mometasone (a corticosteroid), olopatadine (a histamine H1-receptor agonist) or placebo. All trial arms utilized the same vehicle and nasal spray delivery system. The primary endpoint was change from baseline in average morning and evening patient-reported 12-hour reflective Total Nasal Symptom Score (rTNSS). Secondary endpoints include safety and tolerability.
Glenmark Pharmaceuticals is a global innovative pharmaceutical company with operations in more than 80 countries. It has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology.