SOURCE: GlaxoSmithKline

February 27, 2007 12:45 ET

Studies Showed Fluticasone Furoate Nasal Spray Was Well-Tolerated and Effective in Treating Allergic Rhinitis in Pediatric Patients

Data Presented at AAAAI Demonstrated No Effect on Childhood Growth

SAN DIEGO, CA -- (MARKET WIRE) -- February 27, 2007 -- Four out of every 10 children suffer from severe nasal allergy symptoms that may affect their overall well-being. Now, clinical research suggests that fluticasone furoate nasal spray (FFNS), a once-a-day allergy medicine under Food and Drug Administration review, effectively treats sneezing, runny nose, nasal itching, and nasal congestion in children 2 to 11 years of age with seasonal and year-round nasal allergies. Moreover, the investigational drug had no effect on children's short-term growth.

Data from these studies, including two Phase III trials (poster #1193, 1189) involving more than 1,100 children, were presented today at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). The Phase III studies were designed to evaluate how safe and effective FFNS was in children with either seasonal allergies, which are caused by pollen, or year-round allergies, which are caused by dust mites, mold, and animal dander. In both studies FFNS was found to be effective in reducing nasal symptoms, compared to placebo, and was generally well-tolerated.

In addition, researchers presented data from two studies (poster #1187, 909) 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 (HPA) axis function. Both studies demonstrated that treatment with FFNS did not affect these important indicators of growth and hormonal function.

"Pediatricians and allergists who treat young children need options that will help them safely and effectively manage the symptoms of nasal allergies," said Eli Meltzer, M.D., co-director of the Allergy & Asthma Medical Group and Research Center in San Diego, Calif., who acted as lead investigator on one of the four pediatric studies that were presented at AAAAI. "These encouraging data suggest that FFNS could offer clinicians and parents a viable new treatment option for children with nasal allergies."

FFNS Effective and Well-Tolerated

In a study of 554 children 2 through 11 years of age with seasonal allergies, also known as SAR, researchers concluded that FFNS was effective in providing 24-hour relief from nasal allergy symptoms, including nasal congestion, sneezing, runny and itchy nose. The data showed statistically significant improvement in the primary and all key secondary efficacy endpoints in both the 6 to 11 age group (primary subset) and the entire population. For the primary endpoint, FFNS 110 mcg once-daily significantly reduced seasonal nasal symptoms compared with placebo (-3.16 for FFNS and -2.54 for placebo; p=0.025) for children ages 6 through 11. Similarly, significant improvement in nasal symptoms was reported for the entire study population treated with FFNS 110 mcg (-3.26 for FFNS and -2.65 for placebo; p=0.012). For both the primary subset and the entire population, FFNS demonstrated a 24-hour duration of action (-2.80 for FFNS and -2.13 placebo; p=0.015, and -2.87 for FFNS and -2.23 placebo; p=0.008, respectively). FFNS 55 mcg once-daily showed numerical reductions in the primary and key secondary endpoints, which were not significant when compared with placebo.

FFNS was well-tolerated and no drug-related serious adverse events were identified in this SAR study. The most common adverse event reported was headache, and the most common drug-related adverse event was nosebleed.

Another study compared the effects of long-term treatment with FFNS at 110 mcg and 55 mcg, versus placebo, of year-round allergies in 558 children ages 2 through 11. In this study, efficacy data were analyzed for a subset of patients 6 to 11 years of age. Overall, after four weeks' treatment, for the primary endpoint, study participants were evaluated for reductions in total nasal symptom scores for FFNS compared with placebo. FFNS 110 mcg once-daily showed numerical reductions in the primary endpoint, which were not significant when compared with placebo. FFNS 55 mcg once-daily, for the primary endpoint, significantly reduced year-round nasal symptoms compared with placebo (-4.16 for FFNS and -3.41 for placebo; p=0.003).

FFNS was well-tolerated and no drug-related serious adverse events were identified in this PAR study. The most common adverse events reported were throat pain, nosebleed, and fever.

FFNS Did Not Impact Childhood Safety Markers

In a study evaluating the potential effects of FFNS on lower-leg growth rates, researchers compared a 110 mcg once-daily dose of the medication with placebo over two weeks in 58 children ages 6 through 11. Using a standard measure of lower leg length growth known as knemometric assessment, researchers found that treatment with FFNS was statistically non-inferior to placebo with respect to lower-leg growth rates (mean lower-leg growth rates: FFNS, 0.40 mm/week; placebo, 0.42 mm/week).

Another study looked at the effects of FFNS, compared with placebo, on serum cortisol in children ages 2 through 11 with PAR. Changes in serum cortisol ratios can indicate whether HPA axis suppression is occuring, which would suggest lack of proper endocrine system function. HPA axis is a part of the neuroendocrine system that controls reactions to stress and regulates various body processes. This study demonstrated no effects associated with FFNS on serum cortisol after six weeks of treatment with a 110 mcg once-daily dose. In the study, FFNS was well-tolerated.

About FFNS

Fluticasone furoate nasal spray is an enhanced affinity intranasal corticosteroid (INS) currently in development by GlaxoSmithKline (GSK) for use in the treatment of the symptoms of allergic rhinitis. As an INS, fluticasone furoate blocks the action of inflammatory mediators early in and throughout the allergy process. FFNS has a unique, side-actuated trigger designed for ease-of-use and patient comfort. The new agent is currently under review by the U.S. Food and Drug Administration to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

INS

Intranasal corticosteroids (INSs) effectively reduce the nasal inflammation that is a root cause of allergic rhinitis. By acting early and throughout the allergy process, INSs block more allergy mediators, treating the symptoms caused by nasal inflammation such as nasal congestion, sneezing, and runny or itchy nose. This class of medicine is considered first-line therapy when nasal congestion is the primary symptom of the patient's rhinitis.

About Allergic Rhinitis

Allergic rhinitis (AR), known as nasal allergies, is an inflammatory reaction of the nasal passages to allergens, such as dust mites, animal dander, mold spores, and pollens. One of the most prevalent and chronic diseases in the U.S., nasal allergies affect up to 40 million people annually, including 10 to 30 percent of adults and up to 40 percent of children. Within minutes of exposure to an allergen, immune response cells release inflammatory mediators -- such as histamines and leukotrienes -- that lead to inflammation and produce symptoms including nasal congestion, sneezing and runny or itchy nose. Seasonal allergic rhinitis, triggered by pollens, occurs during certain seasons and lasts a few weeks to a few months. Perennial allergic rhinitis, triggered by dust mites, animal dander, and mold, occurs year-round.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information visit www.gsk.com.

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