Glenmark Pharmaceuticals says that data from a Phase 3 study of its GSP 301 mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis show statistically significant and clinically meaningful improvement in symptoms compared to placebo and to the individual components.
The two-week study enrolled 1,176 patients 12 years old and older and measured change from baseline in patient-reported 12-hour total nasal symptom score. GSP 301 was also well tolerated, with no meaningful difference in adverse events compared to placebo, mometasone, and olopatadine.
Glenmark Pharmaceutical President and Chief Medical Officer Fred Grossman commented, “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.”
The company has not yet published the data.
Read the Glenmark Pharmaceuticals press release.
