Glenmark Pharmaceuticals, a global pharmaceutical company, announces that the U.S. Food & Drug Administration (FDA) has accepted for review the company’s New Drug Application for its 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.
Allergic rhinitis is inflammation of the inside of the nose caused by an allergen. It can also be called hay fever. According to the most recent CDC data, over 17 million adults in the United Sates are affected by seasonal allergic rhinitis every year. It is the primary diagnosis in over 11 million doctor’s visits annually and is estimated to affect more than seven percent of adults aged 18 and over in the United States.
The filing for Ryaltris includes efficacy and safety results from two pivotal, randomised, multicenter, double-blind, placebo-controlled trials in adults and adolescents 12 years of age and older with SAR. The similarly designed trials lasted two weeks and enrolled 2,352 patients. Assessment of efficacy was based on patient-reported reflective total nasal symptom score (rTNSS), along with other patient-reported measures of nasal and ocular symptoms. Across the two studies, treatment with Ryaltris resulted in statistically significant improvements in rTNSS compared to placebo.
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). This trial was a three-arm, double-blind, randomised, parallel group, placebo-controlled safety study that randomized patients to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray.
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, nosebleed and nasal discomfort.
Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals said, “We are pleased that Glenmark’s rigorous study of Ryaltris led to today’s filing acceptance by the FDA. We look forward to offering a potential new treatment option for people suffering from seasonal allergic rhinitis.”