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New Mometasone Furoate Monohydrate Nasal Spray Approved
KENILWORTH, N.J., Aug. 26 /PRNewswire-FirstCall/ -- Schering-Plough Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved a new scent-free formulation of NASONEX® (mometasone furoate monohydrate) prescription nasal inhaled steroid. NASONEX remains the first and only once-daily prescription nasal inhaled steroid approved to help prevent most seasonal nasal allergy symptoms, including nasal congestion, in adults and children 12 years of age and older and the only nasal inhaled steroid approved to treat nasal allergy symptoms, including nasal congestion, in patients as young as 2 years of age.(1) The FDA approval of this new formulation was based upon extensive review of the safety and efficacy data from the original formulation of NASONEX Nasal Spray.
Nasal inhaled steroids are the recommended first line therapy when nasal congestion is the primary symptom of a patient's allergic rhinitis, according to The Allergy Report, which was developed by the American Academy of Allergy, Asthma & Immunology (AAAAI).(2)
About Nasal Allergies
Nasal allergies caused by allergic rhinitis, which is considered to encompass the outdoor symptoms of seasonal allergic rhinitis (SAR) and the indoor symptoms of perennial allergic rhinitis (PAR), affect approximately 36 million people in the United States.(3) An estimated 40 to 50 percent of people with allergies are believed to suffer from both SAR and PAR; 20 to 30 percent from SAR alone; and 15 to 30 percent from PAR alone, according to Decision Resources, Inc. Seasonal nasal allergy symptoms, which classically include sneezing, itching, nasal discharge, and congestion, can have a significant impact on everyday activities at work, school and leisure time.
A recent survey of more than 2,000 people found nasal congestion is the most bothersome symptom for those with allergic rhinitis, particularly for children with allergic rhinitis, and it is the most difficult symptom of allergic rhinitis to manage.(4) In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions such as asthma.
NASONEX is a nasal inhaled steroid related to cortisol, a hormone produced naturally by the body, and when used as directed, is safe, nonsedating and not addictive.(1) NASONEX reduces nasal congestion caused by an allergic reaction. NASONEX provides relief from symptoms of seasonal and perennial allergic rhinitis, including nasal congestion, sneezing and an itchy, runny nose. Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds, and coughing.(1) Visit http://www.nasonex.com/ for more information on preventing and treating seasonal nasal allergies. For additional important safety information, full prescribing information is available at: http://www.spfiles.com/pinasonex.pdf.
* Based on the anhydrous basis. 1. NASONEX® Product Information. Schering Corporation. 2. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000, Vol. 2:p.16. 3. Natahn, R.A., Meltzer, E.O., Selner, J.C., Storms, W. "Prevalence of Allergic Rhinitis in the United States." Journal of Allergy and Clinical Immunology (1997) 99:S808-14. 4. Impact of Nasal Congestion Among Allergic Rhinitis Sufferers. Roper Public Affairs and Media. July 2004.