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GSK files for rhinitis drug in US and Europe

LondonTuesday, August 1, 2006, 08:00 Hrs  [IST]

GlaxoSmithKline (GSK) has submitted applications for US and Europe, marketing approval for a new medicine, to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The medicine (fluticasone furoate) is an enhanced affinity intranasal corticosteroid with the proposed name of Allermist in the US and Avamys in Europe, a GSK release stated. The efficacy and safety of Allermist and Avamys have been evaluated in seven clinical trials with 2,555 adult and paediatric patients two years of age and older with symptoms of SAR and PAR. Patients taking the medicine reported significant improvements in a range of nasal symptoms compared to those taking a placebo. In adult patients with SAR, in addition to nasal symptom improvement, Allermist and Avamys use was also consistently associated with significant improvement in ocular symptoms such as watery, itchy eyes. This is an important milestone in our respiratory research and we hope this medicine will offer help to millions of seasonal and perennial allergy patients," stated Kathy Rickard, M.D., vice president clinical, Respiratory Medicine Development Centre (North America). Developed after ergonomic testing, Allermist and Avamys are dispensed using a novel nasal device, designed with the patient in mind. There is minimal or no aftertaste with Allermist and Avamys and the product is unscented and alcohol-free. Allergic rhinitis is an inflammatory disease characterized by the symptoms of runny nose (rhinorrhea), nasal congestion, watery eyes, sneezing and itching of the nose and ocular symptoms of red, itching, burning and watery eyes.

 
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