Express Pharma

Glenmark bags FDA acceptance for Ryaltris

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The drug is used for patients suffering from seasonal allergic rhinitis

Glenmark Pharmaceuticals announced that the US Food & Drug Administration (FDA) 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 FDA as the brand name.

“We are pleased that Glenmark’s rigorous study of Ryaltris led to today’s filing acceptance by the FDA,” said Fred Grossman, President and Chief Medical Officer, Glenmark Pharmaceuticals. “We look forward to offering a potential new treatment option for people suffering from seasonal allergic rhinitis.”

The filing for Ryaltris includes efficacy and safety results from two pivotal, randomised, multi-centre, 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 randomised patients to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. The study also evaluated efficacy as a secondary endpoint, assessed as change from baseline in average morning patient-reported rTNSS. Ryaltris demonstrated a statistically significant and clinically meaningful improvement compared to placebo (p<0.0001) over 52 weeks of treatment.

The incidence of adverse reactions in four placebo-controlled clinical studies was 13.9 per cent in the Ryaltris treatment groups versus 9.5 per cent of patients in the placebo groups. The most frequently reported adverse reactions with Ryaltris greater than placebo was loss of taste sensitivity (3.0 per cent vs. 0.3 per cent , respectively), nosebleed (1.0 per cent vs. 0.6 per cent) and nasal discomfort (1.0 per cent vs.0.8%).

 

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