Novel Allergic Rhinitis Nasal Spray Shows Promise in Phase 3 Trial

The trial enrolled 1,176 individuals aged ≥12 years and lasted for a total of 14-days.
The trial enrolled 1,176 individuals aged ≥12 years and lasted for a total of 14-days.

Glenmark announced positive results from a Phase 3 trial investigating their nasal spray, GSP 301, a potential treatment for seasonal allergic rhinitis.

GSP 301 includes a fixed-dose combination of mometasone furoate (25mcg) and olopatadine hydrochloride (665mg) and is designed to be administered twice-daily. The trial enrolled 1,176 individuals aged ≥12 years and lasted for a total of 14-days. Using the same delivery system, participants were administered either GSP 301, mometasone (corticosteroid), olopatadine (histamine H1-receptor agonist) or a placebo, twice daily.

The primary endpoint was change from baseline in average morning and evening patient-reported 12-hour reflective Total Nasal Symptom Score (rTNSS). 

Results showed that GSP 301 was tied to statistically significant improvements from baseline for the primary endpoint when compared to placebo (P<0.001), olopatadine (P=0.028), and mometasone (P=0.019). No meaningful adverse events were reported across the study arms.

Full data from the trial has not yet been released. Glenmark is planning to submit the trial results for presentation at upcoming scientific meetings and publication in a peer-reviewed journal.

For more information visit Glenmarkpharma.com.