Ryaltris is for seasonal allergic rhinitis and it is formerly known as GSP 301 nasal spray, and it is the company’s leading respiratory pipeline asset
Glenmark Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for its respiratory pipeline candidate Ryaltris (rye – al’ – tris), an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg), formerly GSP 301 nasal spray, has been conditionally accepted by the FDA as the brand name.
“Our first NDA submission with Ryaltris is the culmination of years of diligent effort by our employees and clinicians,” said Fred Grossman, President and Chief Medical Officer, Glenmark Pharmaceuticals. “This is an important milestone for Glenmark, and another step in our rapid transition into becoming an innovation-led and discovery-driven life sciences company.”
Glenmark expects the FDA will determine whether the NDA is complete for filing within 60 days. If the NDA is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time.
Glenmark has studied Ryaltris in seven clinical trials involving more than 4,000 patients. phase III results of Ryaltris have been previously presented at key medical meetings, most recently at the Joint Congress of the American Academy of Allergy, Asthma and Immunology and the World Allergy Organisation held in March 2018.
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