Phase III trial of GSP 301 (mometasone furoate and olopatadine hydrochloride) shows significant improvement in seasonal allergic rhinitis- Glenmark Pharmaceuticals

Glenmark Pharmaceuticals announced positive results for GSP 301, (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. In the trial treatment with GSP 301 demonstrated statistically significant and clinically meaningful improvement from baseline in average morning and evening patient-reported rTNSS, compared to placebo (p <0.001), olopatadine (p="0.028)," and mometasone (p="0.019).">

These results are from a recently completed Phase III trial assessing the efficacy and safety of GSP 301 combination therapy versus mometasone, olopatadine or placebo. This Phase III, 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.

All investigational treatments administered in the trial were well-tolerated, and showed no meaningful differences in reported adverse events (AEs) across study arms. The most common AE occurring in at least 2 percent of patients was dysgeusia. Data from this trial have not yet been published. Glenmark will be submitting these data for presentation at upcoming scientific meetings and publication in a peer-reviewed journal.