The safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, were established in three large 2-week seasonal allergic rhinitis studies. The objective of the study was to evaluate long-term (52 weeks) safety and efficacy of GSP301 in patients with perennial allergic rhinitis (PAR). In this randomized, double-blind, parallel-group study, 601 patients (aged ≥ 12 years) with PAR were randomized 4:1:1 to twice-daily GSP301 (olopatadine 665 μg and mometasone 25 μg [pH 3.7]) or two GSP301 vehicle formulations (placebo pH 3.7 or 7.0).
Results: PNSS and the quality of life were significantly improved versus placebo pH 3.7 at week 6. However, these greater improvements did not reach statistical significance at the end of the study.
Conclusion: Twice-daily GSP301 was well tolerated and provided statistically significant and clinically meaningful improvements in allergic rhinitis nasal symptoms versus placebo over 52 weeks and demonstrated a favorable safety profile and efficacy.