Dec 14: Glenmark Pharmaceuticals Ltd, a global pharmaceutical company, on Thursday announced that it met its primary clinical endpoint in a Phase 3 study evaluating the safety of its ‘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).
According to Glenmark, it is planning 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.
“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,” the company said.
It further said that for the primary endpoint, all treatments administered in the trial were well-tolerated, and the majority of treatment emergent adverse events (TEAEs) were mild-to-moderate in severity. The most frequent TEAEs reported with Ryaltris included nosebleeds (4.6%), headache (4.1%) and a decrease in taste sensitivity (2.0%). In addition, on the secondary efficacy endpoint, treatment with Ryaltris demonstrated statistically significant and clinically meaningful improvement from baseline in average morning patient-reported rTNSS, compared to placebo (p<0.0001) over 52 weeks of treatment.
“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.”
Meanwhile, the company also informed that data from this trial have not yet been published.
“Glenmark will be submitting these data for presentation at upcoming scientific meetings and publication in a peer-reviewed journal,” it said.