Mumbai, May 9: Pharma Major, Glenmark Pharmaceuticals, on Thursday 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 Symptom Score (rTNSS) compared to placebo.1 Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name, a release said.
''It has become increasingly important to conduct studies specifically designed for pediatric patients, so that we may gain insights into potential differences in safety, efficacy and dosing compared to studies in adult and adolescent populations,'' said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals.
Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). (UNI)