Positive Phase III results for Ryaltris in perennial allergic rhinitis

In a Phase III study evaluating the safety of Ryaltris (mometasone furoate 25mcg) and olopatadine hydrochloride 665mcg), an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR), the drug met its primary clinical endpoint.

Ryaltris has been conditionally accepted as the brand name for GSP 301 Nasal Spray by the US Food and Drug Administration (FDA), said the drug’s developer, Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296).

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 2018.