Glenmark Pharma Reports Positive Results From A Phase 3 Trial Of GSP 301


Glenmark Pharmaceuticals, a global pharmaceutical company, on Thursday 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.

This Phase 3, 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.

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 percent of adults aged 18 and over in the United States. As of January 2017 the annual value of the U.S. nasal spray market was $1.3 billion.

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries.

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