Glenmark's Phase 3 Safety Study Evaluating Ryaltris in Patients with PAR Meets Primary Endpoint

Glenmark Pharmaceuticals, a Rs. 8,950 crore plus pharma major from Mumbai, announced that the company met its primary clinical endpoint in a phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR).

Ryaltris has been conditionally accepted as the brand name for GSP 301 nasal spray by the US Food & Drug Administration (FDA). Glenmark plans to submit the company's first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018.

"Ryaltris has been extensively studied in three phase 3 trials for SAR, and we are pleased that the addition of this long-term study in patients suffering with PAR met the primary safety and secondary efficacy endpoints. Collectively, these data suggest that Ryaltris is effective and well -tolerated," said Fred Grossman, president and chief medical officer at Glenmark Pharmaceuticals. "We have worked closely with the FDA on the clinical development program for Ryaltris, and look forward to providing robust data to support its potential approval."

This phase 3, US-based trial was a three-arm, double-blind, randomized, parallel group, placebo-controlled safety study that enrolled 601 adults and adolescents 12 years of age and older with at least a two-year history of PAR. Patients were randomized to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. All trial arms used the same nasal spray delivery system.