Glenmark Pharma reports results of Phase 3 study of Ryaltris

Glenmark Pharmaceuticals announced positive results from a Phase 3 study of Ryaltris, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis(SAR). The study in patients aged 6 to under 12 years met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Score (rTNSS) compared to placebo. Ryaltris and mometasone furoate, also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.

The primary objective of the Phase 3 study was to compare the effectiveness of Ryaltris (administered as one spray in each nostril, twice daily) versus a placebo nasal spray over 14 days in paediatric subjects with SAR. Glenmark Pharma has studied Ryaltris in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). Results from those clinical trials of Ryaltris have been previously presented at key medical meetings and full results from the study of Ryaltris in pediatric patients will be published and presented at future meetings.

On Thursday, the stock of Glenmark was trading at Rs. 610.45 per share, up 1.26 per cent on the BSE.