GSK ANNOUNCES PEDIATRIC DATA ON NASAL SPRAY

GlaxoSmithKline (GSK) has presented data showing that that fluticasone furoate nasal spray (FFNS), a once-a-day allergy medicine under FDA review, effectively treats sneezing, runny nose, nasal itching and nasal congestion in children 2 to 11 years old with seasonal and year-round nasal allergies. Moreover, the investigational drug had no effect on children's short-term growth.

The results were from two Phase III trials involving more than 1,100 children that were designed to evaluate how safe and effective FFNS was in children with either seasonal allergies or year-round allergies. In both studies FFNS was found to be effective in reducing nasal symptoms, compared with placebo, and was generally well-tolerated.

In addition, GSK announced data from two studies that evaluated whether FFNS affected key safety measures in children, including short-term lower-leg growth and a hormonal process known as hypothalamic-pituitary-adrenal axis function. Both studies demonstrated that treatment with FFNS did not affect these indicators of growth and hormonal function.

FFNS is an enhanced affinity intranasal corticosteroid currently in development for use in the treatment of the symptoms of allergic rhinitis. Fluticasone furoate blocks the action of inflammatory mediators early in and throughout the allergy process.