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New Data Shows Veramyst Effectively Treats Symptoms of Perennial Allergic Rhinitis
Date:11/11/2007

Study Also Demonstrated Significant Improvement in Eye Symptoms

DALLAS, Nov. 11 /PRNewswire/ -- Veramyst(TM) (fluticasone furoate) Nasal Spray demonstrated significant improvement in the treatment of nasal and ocular allergy symptoms of perennial allergic rhinitis (PAR) in patients 12 years of age and older, according to a clinical study presented today at the annual scientific meeting of the American College of Allergy, Asthma & Immunology (ACAAI).

Perennial allergic rhinitis, or PAR, refers to allergy symptoms that occur year-round in response to triggers such as dust mites, animal dander and mold. Seasonal allergic rhinitis, or SAR, refers to only seasonal symptoms, for example an allergic response to springtime pollen.

Results of this 6-week global clinical study showed that Veramyst 110 mcg administered once-daily was significantly more effective than placebo in relieving overall nasal allergy symptoms (nasal congestion, rhinorrhea, sneezing and nasal itching), the primary efficacy endpoint. Veramyst also showed statistically significant improvement in relieving overall eye symptoms (itching/burning, tearing/watering and eye redness), a secondary study endpoint. Veramyst administered once-daily also provided sustained, 24-hour efficacy for both nasal and eye symptoms of perennial allergies.

"This study demonstrated the efficacy of Veramyst for patients suffering from both nasal and ocular symptoms all year long, not just during spring and fall allergy seasons," said study author Eli Meltzer, M.D., co-director of the Allergy & Asthma Medical Group and Research Center in San Diego, Calif. "The 24-hour relief from symptoms is also a key patient benefit."

In the 6-week double-blind, placebo-controlled study, 302 individuals 12 years of age and older, were randomized to receive either Veramyst 110 mcg once daily or placebo. Patients rated their nasal symptoms (nasal congestion, itching, rhinorrhea and sneezing) and eye symptoms (eye itching/burning, tearing/watering and redness) on a patient-rated scale at baseline and after six weeks.

Veramyst was associated with statistically significantly greater improvement in nasal symptoms than placebo; the mean change from baseline was -3.95 for Veramyst versus -2.69 for placebo (p<0.001). Patients taking Veramyst likewise reported significantly greater improvement in eye symptoms versus those taking placebo (-1.92 mean change from baseline versus -1.41 for placebo; p=0.004). Furthermore, patients taking Veramyst experienced sustained 24-hour relief from nasal symptoms, as measured by the mean change from baseline in next-day pre-dose symptom scores (-3.82 for Veramyst versus -2.36 for placebo; p<0.001) and eye symptoms (-1.76 for Veramyst versus -1.26 for placebo; p=0.007).

In this study, the most common drug-related adverse event reported was epistaxis or nosebleed (8% Veramyst 110 mcg; 4% placebo group). The incidence of laboratory abnormalities was low, and ECG and vital sign changes were minor and similar between the two groups.

About Veramyst

Veramyst Nasal Spray is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis in adults and in children age two years and older.

In a prior 4-week study, patients 12 years of age and older with perennial allergic rhinitis who were treated with Veramyst 110 mcg once daily did not experience statistically significant improvement in ocular symptom scores.

Veramyst is delivered using a device that has a side-actuated "mist release" button that, when pressed, delivers the same amount of medicine every time* in a gentle fine mist.

*Veramyst should not be used after 120 sprays (after initial priming) because consistent dosing cannot be assured even though the bottle may not be completely empty.

Important Information about Veramyst

Side effects include nosebleed or nasal sores. Nasal fungal infection, glaucoma or cataracts may occur. Have regular eye exams. Do not spray in eyes.

For best results use Veramyst once daily. Maximum relief may take several days. Results may vary. To learn more about prescription Veramyst, talk to your doctor.

About Intranasal Corticosteroids

The way intranasal corticosteroids (INSs) work is not fully understood but by acting early and throughout the allergy process, INSs work a on whole range of chemicals that lead to symptoms 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 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 (NYSE: GSK) 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 http://www.gsk.com.


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SOURCE GlaxoSmithKline
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