Ryaltris Safe, Effective for Pediatric Patients in Seasonal Allergic Rhinitis Trial

A new PDUFA date for the treatment is now June 21, 2019; the FDA did not request additional studies from the Company.

Findings from a phase 3 study evaluating Ryaltris (olopatadine HCl, mometasone furoate; Glenmark), an investigational fixed-dose combination nasal spray, showed that the treatment was safe and effective in patients 6 to <12 years of age with seasonal allergic rhinitis (SAR).

Ryaltris contains olopatadine HCl 665mcg, an antihistamine, and mometasone furoate 25mcg, a steroid. In the trial, patients (N=446) were randomized to receive Ryaltris or placebo nasal spray for 14 days; the primary outcome measure of the study was the change from baseline in average AM and PM patient-reported 12-hour reflective Total Nasal Symptom Score (rTNSS), the sum of the severity of 4 nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing).

Results showed that treatment with Ryaltris led to a statistically significant improvement in the average AM and PM rTNSS (P =.001) compared with placebo. With regard to safety, the most common treatment-emergent adverse reactions reported included distortion of taste sensation, headache, and nose bleed.

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“We are pleased to report that the safety and effectiveness observed in this pediatric population is consistent with our overall phase 3 development program in SAR patients 12 years of age and older,”  said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals. “These robust data contribute to the extensive clinical background supporting the effectiveness and tolerability of Ryaltris.”

In August 2018, Glenmark announced that the Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for Ryaltris for the treatment of SAR in patients ≥12 years old. A Prescription Drug User Fee Act (PDUFA) date of March 21, 2019 had been assigned, however the FDA notified Glenmark that additional time would be needed to review the application. As such, the new PDUFA date is now June 21, 2019; the FDA did not request additional studies from the Company.

For more information visit glenmarkpharma-us.com.