– Ryaltris (mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg)), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name
– Glenmark remains on course to file the company’s first New Drug Application in the first quarter of CY 2018
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that it met its primary clinical endpoint in a Phase 3 study evaluating the safety of Ryaltris™ (RY • al • tris), 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 U.S. 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, U.S.-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. The study also assessed efficacy, as change from baseline in average morning patient-reported reflective Total Nasal Symptom Score (rTNSS), as a secondary endpoint.
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.
“Glenmark has rapidly evolved from a company with a thriving generic pharmaceutical business to one that is also discovering new treatments, and researching devices that deliver these treatments in new ways,” said Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals. “Ryaltris is an important first step in this evolution, and the realization of the potential in Glenmark’s pipeline has only just begun. Over the next 10 years, Glenmark believes that the investments made in the Company’s robust pipeline will continue to produce a variety of new and innovative treatment options.”
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