KENILWORTH, N.J., Jan. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the new scent-free, alcohol-free formulation of NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg* is now available nationwide. The safety and efficacy of the scent-free, alcohol-free formulation was approved by the U.S. Food and Drug Administration (FDA) in August 2004.
NASONEX remains the 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 when NASONEX is started 2 to 4 weeks prior to allergy season, and the only nasal inhaled steroid approved to treat nasal allergy symptoms, including nasal congestion, in patients as young as 2 years of age. NASONEX also is the first and only nasal inhaled steroid approved for the treatment of nasal polyps in adults 18 years of age and older.(1)
In a survey of more than 2,000 allergic rhinitis sufferers, 76 percent of patients said they would choose a scent-free product, when all other attributes, such as safety and efficacy, are equal.
"Schering-Plough is committed to developing innovative products to improve the health and quality of life of allergy sufferers," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough. "We listened to allergic rhinitis patients to help guide us in the development of scent-free NASONEX."
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)
"Nasal inhaled steroids are the most effective medicines for treating and preventing nasal allergy symptoms, especially the most annoying symptom, nasal congestion," said Eric Schenkel, M.D., a specialist in allergy and immunology based in Easton, Pa. "And when given a choice, my patients typically would rather use a scent-free nasal inhaled steroid."
The FDA approved the new scent-free formulation on Aug. 26, 2004 following a review of a New Drug Application (NDA) Supplement and the safety and efficacy data from the original formulation of NASONEX Nasal Spray.
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.(4) 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. In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions such as asthma.
Nasal congestion is the most bothersome symptom for patients with allergic rhinitis, particularly for children with allergic rhinitis, and is the most difficult symptom of allergic rhinitis to manage.(5)
About Nasal Polyps
The prevalence of nasal polyps increases with age and the condition affects up to 11 million people in the United States.(6) Symptoms of nasal polyps include long-term nasal congestion, diminished sense of smell, runny nose, chronic sinus infections, headaches or snoring. Surgical removal is commonly used as a last resort.
Originally approved in 1997, 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) As a pharmaceutical preparation, which contains no ethanol or ethyl alcohol, new scent-free NASONEX is alcohol- free. 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) NASONEX also is the first and only nasal inhaled steroid approved for the treatment of nasal polyps in adults 18 years of age and older. 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.
NASONEX builds upon Schering-Plough's heritage as a leader in discovery and development. Products from the company's research efforts include the CLARITIN(R) (loratadine) family of nonsedating antihistamines and CLARINEX(R) (desloratadine) syrup and tablet.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements within the meaning of the Securities Litigation Reform Act of 1995 concerning NASONEX, the market for drugs to treat allergic rhinitis and the market for drugs to treat nasal polyps. Forward-looking statements relate to expectations or forecasts of future events and use words such as "will" and "would." Actual results may vary from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough's forward-looking statements. These factors include market acceptance of new products and new indications, product availability, current and future branded, generic and OTC competition, the regulatory process for new products and new indications, timing of trade buying, manufacturing issues, and matters impacting patents on Schering-Plough products. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the 2004 third quarter 10-Q.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. For additional information, visit http://www.schering-plough.com/.
* Calculated on the anhydrous basis.
(1) NASONEX(R) 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) (C) Decision Resources, Inc.
(5) Impact of Nasal Congestion Among Allergic Rhinitis Sufferers. Roper
Public Affairs and Media. July 2004.
(6) Mygrind N., Dahl R., Rachert C. Nasal polyposis, eosinophil dominated
inflammation, and allergy. Thorax. 2000;5S(Suppl 2):S79-S83.