Glenmark Pharmaceuticals, a global pharmaceutical company, has announced 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.
Fred Grossman, D O President and chief medical officer of Glenmark, said, “We continue to advance our respiratory pipeline and are pleased to report positive results of GSP 301 in seasonal allergic rhinitis. The number of people affected by seasonal allergic rhinitis is steadily growing, and there are limited FDA approved combination treatments, therefore there is a need for additional, potentially effective treatment options.”
This phase 3, US-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.
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). 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 per cent 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.
According to the most recent data, over 17 million adults and 6 million children in the United States are affected by seasonal allergic rhinitis, also called hay fever, every year. It is the primary diagnosis in over 11 million doctor’s visits and is estimated to affect more than seven per cent of adults aged 18 and over in the United States. As of January 2017 the annual value of the US nasal spray market was $1.3 billion.