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New Data Shows Veramyst Effectively Treats Symptoms of Perennial Allergic Rhinitis

Monday, November 12, 2007 General News J E 4
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DALLAS, Nov. 12 Veramyst(TM) (fluticasone furoate) NasalSpray demonstrated significant improvement in the treatment of nasal andocular allergy symptoms of perennial allergic rhinitis (PAR) in patients 12years of age and older, according to a clinical study presented at the annualscientific meeting of the American College of Allergy, Asthma & Immunology(ACAAI).

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

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

"This study demonstrated the efficacy of Veramyst for patients sufferingfrom both nasal and ocular symptoms all year long, not just during spring andfall allergy seasons," said study author Eli Meltzer, M.D., co-director of theAllergy & Asthma Medical Group and Research Center in San Diego, Calif. "The24-hour relief from symptoms is also a key patient benefit."

In the 6-week double-blind, placebo-controlled study, 302 individuals 12years of age and older, were randomized to receive either Veramyst 110 mcgonce 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 aftersix weeks.

Veramyst was associated with statistically significantly greaterimprovement in nasal symptoms than placebo; the mean change from baseline was-3.95 for Veramyst versus -2.69 for placebo (p<0.001). Patients takingVeramyst likewise reported significantly greater improvement in eye symptomsversus those taking placebo (-1.92 mean change from baseline versus -1.41 forplacebo; p=0.004). Furthermore, patients taking Veramyst experienced sustained24-hour relief from nasal symptoms, as measured by the mean change frombaseline in next-day pre-dose symptom scores (-3.82 for Veramyst versus -2.36for placebo; p<0.001) and eye symptoms (-1.76 for Veramyst versus -1.26 forplacebo; p=0.007).

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

About Veramyst

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

In a prior 4-week study, patients 12 years of age and older with perennialallergic rhinitis who were treated with Veramyst 110 mcg once daily did notexperience statistically significant improvement in ocular symptom scores.

Veramyst is delivered using a device that has a side-actuated "mistrelease" button that, when pressed, delivers the same amount of medicine everytime* 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 becompletely 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 e
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