Aug 8: Mumbai-based Glenmark Pharmaceuticals, a global pharmaceutical company, on Wednesday announced that the US Food & Drug Administration (USFDA) has accepted for review the company’s New Drug Application for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, has been conditionally accepted by the USFDA as the brand name, it said.
According to the company, the filing for Ryaltris includes efficacy and safety results from two pivotal, randomized, multicenter, double-blind, placebo-controlled trials in adults and adolescents 12 years of age and older with SAR.
Additionally, the filing includes data from a long-term safety study in 601 adults and adolescents 12 years of age and older with perennial allergic rhinitis (PAR).
“The incidence of adverse reactions in four placebo-controlled clinical studies was 13.9% in the Ryaltris treatment groups versus 9.5% of patients in the placebo groups. The most frequently reported adverse reactions with Ryaltris greater than placebo was loss of taste sensitivity (3.0% vs. 0.3%, respectively), nosebleed (1.0% vs. 0.6%) and nasal discomfort (1.0% vs. 0.8%),” the company said.