Glenmark Pharma Receives FDA Approval for Ryaltris Nasal Spray for the Treatment of Seasonal Allergic Rhinitis in Patients 12 Years and Older

Glenmark Pharma Receives FDA Approval for Ryaltris Nasal Spray for the Treatment of Seasonal Allergic Rhinitis in Patients 12 Years and Older

Glenmark Pharmaceuticals announced the FDA has approved Ryaltris, a fixed-dose (metered) combination nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States. The recommended dose is 2 sprays in each nostril twice daily. The NDA was originally filed in May of 2018 however the FDA issued a Complete Response Letter in June of 2019. The issues were not specified, but Glenmark did state the concerns didn’t pertain to the clinical trial data in the NDA. 

Pooled data from clinical studies of Ryaltris (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray) were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019). In the trials, involving more than 2,900 patients, treatment with Ryaltris demonstrated significant and clinically meaningful improvements in average morning and evening reflective Total Nasal Symptoms Scores (rTNSS) and instantaneous TNSS versus placebo. Similarly, Ryaltris provided significant and clinically meaningful improvements in rTNSS and iTNSS versus the monotherapy active controls (olopatadine and m...

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