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US regulators approve GSK’s allergy nasal spray

GlaxoSmithKline said that the FDA has approved its once-daily Veramyst nasal spray to treat seasonal and year-round allergy symptoms in adults and children two years of age and older.

Veramyst is the first prescription nasal steroid spray to demonstrate consistent and significant improvement in relieving overall allergic eye symptoms, which included red, itchy and watery eyes, in patients with seasonal allergies 12 years of age and older in three prospectively designed studies. Veramyst will be available by prescription nationwide by late May 2007.

“Nasal allergies often affect both the nose and the eyes,” said Robert Nathan, principal investigator of a phase III study of Veramyst. “Besides relieving a broad range of nasal allergy symptoms, Veramyst may also help relieve red, itchy and watery eyes in seasonal allergy patients 12 years and older.”

Veramyst is an intranasal corticosteroid that works throughout the allergy process to block an entire range of the chemicals in the body that are involved in inflammation that may lead to nasal allergy symptoms. However, the precise mechanism through which Veramyst affects allergy symptoms is not known.