FDA Approves Once-Daily Veramyst (fluticasone furoate) Nasal Sprayfor Treatment of Seasonal and Year-Round Allergy Symptoms in Adultsand Children as Young as Two Years
New Treatment Has Shown Benefit in Both Nasal and Ocular Symptoms in Seasonal Allergy Patients 12 Years of Age and Older
RESEARCH TRIANGLE PARK, N.C., April 27, 2007 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration today approved once-daily Veramyst (fluticasone furoate) Nasal Spray to treat seasonal and year- round allergy symptoms in adults and children two years of age and older. Veramyst will be available by prescription nationwide by late May 2007.
In clinical trials, Veramyst relieved overall nasal symptoms of seasonal and year-round allergies, which included nasal congestion, sneezing, itchy nose and runny nose. In addition, Veramyst is the first prescription nasal steroid spray to demonstrate consistent and significant improvement in relieving overall allergic eye symptoms, which included red, itchy and watery eyes, in patients with seasonal allergies 12 years of age and older in three prospectively designed studies.
Veramyst is delivered in a unique, ergonomically designed device that was developed to address patient concerns. Veramyst has a side-actuated "mist release" button that, when pressed, delivers the same amount of medicine every time - an important feature for patients who want to know they are getting the full dose that their doctor has prescribed. The device delivers a gentle, scent-free mist with a low volume of spray. The new device also has a viewing window that allows patients to see how much medicine is left.
"Nasal allergies often affect both the nose and the eyes," said Robert Nathan, M.D., Clinical Professor of Medicine at the University of Colorado Health Sciences Center, Department of Internal Medicine, and principal investigator of a Phase III study of Veramyst. "Besides relieving a broad range of nasal allergy symptoms, Veramyst may also help relieve red, itchy and watery eyes in seasonal allergy patients 12 years and older. I'm excited about sharing this new option with my patients."
Veramyst is an intranasal corticosteroid (INS) that works throughout the allergy process to block an entire range of the chemicals in the body that are involved in inflammation that may lead to nasal allergy symptoms. However, the precise mechanism through which Veramyst affects allergy symptoms is not known.
Clinical Trials Demonstrated Efficacy in Broad Range of Symptoms in Adults and Children
The approval of Veramyst was based on clinical trials of more than 2,900 adults and children who suffer from seasonal or year-round allergies.
Veramyst was proven effective for relieving the symptoms of seasonal and year-round allergies in adults and adolescents 12 years of age and older in five clinical trials involving a total of 1,829 patients. In each study, Veramyst was more effective than placebo in relieving overall nasal allergy symptoms. In addition, a key secondary endpoint in three seasonal allergy studies showed that Veramyst was significantly better than placebo in relieving overall ocular symptoms, including red, itchy and watery eyes, in patients 12 years of age and older. Importantly, in all studies, Veramyst sustained its effectiveness for a full 24 hours.
"With its proven efficacy in treating nasal symptoms, as well as ocular symptoms in seasonal allergy patients 12 years of age and older, Veramyst may offer appropriate allergy patients the convenience of a single once-daily treatment to relieve their nasal and eye symptoms," said Dr. Nathan.
In addition, in Phase III studies involving 1,112 children with seasonal or year-round allergies two to 11 years of age, once-daily Veramyst effectively treated overall nasal symptoms, which included congestion, sneezing, itchy nose and runny nose.
Improvement in eye symptoms was not shown in patients 12 years and older with year-round allergies or in patients two to 11 years of age with seasonal or year-round allergies.
Veramyst Improved Quality of Life Endpoints
Adult and adolescent patients with seasonal allergies 12 years of age and older taking Veramyst also reported statistically significant and clinically meaningful improvements in overall allergy-related quality of life (QOL) scores compared with placebo. QOL measures included the impact of treatment on activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional problems. In adult and adolescent patients with year-round allergies, improvements in QOL scores were not statistically significant compared with placebo.
Well-Tolerated in Adults and Children
Patients who took Veramyst in clinical trials experienced adverse reactions with approximately the same frequency as those who received placebo. Common adverse reactions included headache, nose bleed and nasal sores. Fever occurred more frequently in children aged two to 11 taking Veramyst than in the placebo group.
The recommended starting dose is 110 mcg (two mists per nostril) once daily for patients 12 years of age and older. When symptoms have been controlled the dosage may be reduced to 55 mcg (one mist in each nostril once daily). The recommended starting dose is 55 mcg (one mist per nostril) once daily for children two to 11 years of age. Children not adequately responding to 55 mcg may use 110 mcg once daily. Once symptoms have been controlled, the dosage may be decreased to 55 mcg once daily.
About Allergic Rhinitis
Allergic rhinitis, 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 United States, nasal allergies affect up to 40 million people, 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 chemicals such as histamine and leukotrienes that lead to inflammation and may 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.
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 http://www.gsk.com. To access Veramyst media relations materials visit http://www.gsk.com/.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the
Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.
CONTACT: US Media inquiries, Holly Russell or Mary Anne Rhyne,+1-919-483-2839; or UK Media inquiries, Phil Thomson, Joss Mathieson, orGwenan White, (020) 8047 5502; or US Analyst-Investor inquiries, FrankMurdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419; or EuropeanAnalyst- Investor inquiries, Anita Kidgell, (020) 8047 5542, David Mawdsley(020) 8047-5564, or Sally Ferguson, (020)8047-5543, all for GlaxoSmithKline
Web site: http://www.gsk.com/
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Posted: April 2007
- New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval - July 27, 2006
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