New Delhi: Glenmark Pharmaceuticals said it has completed phase 3 study of its investigational fixed-dose combination nasal spray and plans to submit a new drug application with the US health regulator.
In a BSE filing, Glenmark said it met its primary clinical endpoint in a phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, used to treat seasonal allergic rhinitis.
Glenmark plans to “submit the company’s first new drug application (NDA) to the USFDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of the calendar year 2018,” it added.
The company said Ryaltris has been conditionally accepted as the brand name for GSP 301 Nasal Spray by the US Food and Drug Administration (USFDA).
“We have worked closely with the USFDA on the clinical development programme for Ryaltris, and look forward to providing robust data to support its potential approval,” Glenmark Pharmaceuticals President and Chief Medical Officer Fred Grossman said.
This Phase 3, US-based trial was a study that enrolled 601 adults and adolescents, 12 years of age and older, with at least a two-year history of perennial allergic rhinitis.
Patients were randomised to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray, the filing said.