NASONEX(R) Now FDA-Approved in USA for Nasal Polyps

Main Category: Respiratory / Asthma
Article Date: 17 Dec 2004 - 10:00 PDT


First and only nasal inhaled steroid in US for treatment of this condition -

Schering-Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg* for the treatment of nasal polyps in patients 18 years of age and older.(1) This marks the first and only FDA-approval of a nasal inhaled steroid for the treatment of this condition prior to surgery. Nasal polyps are grape-like growths in the nasal cavity that reduce airflow in the nasal passages, leading to congestion.

"The approval of NASONEX for the treatment of nasal polyps provides patients with a safe and effective first-line treatment that delivers medicine directly to the problem area," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough. "NASONEX, used once or twice daily, reduces nasal polyps and relieves symptoms, including congestion."

The new indication for NASONEX is based on data submitted from two controlled trials involving 664 patients 18 to 86 years of age. Patients received either NASONEX 200 mcg once daily, NASONEX 200 mcg twice daily or a placebo. In the first study, a statistically significant reduction in polyp grade was observed at the four-month endpoint in patients receiving NASONEX 200 mcg either once or twice daily, compared to the placebo group. In the second study, patients receiving NASONEX twice daily demonstrated significant reduction of polyp grade compared to the placebo group, and patients receiving once-daily administration demonstrated a numerical but not significant reduction in polyp grade. Both studies showed a statistically significant reduction in congestion for both doses versus the placebo group. Based on the data, the approved indication recommends a 200 mcg dose given twice-daily. A dose of 200 mcg once-daily also is effective in some patients.

On Nov. 24, NASONEX received approval for the treatment of nasal polyps in 13 European countries via the European Union's Mutual Recognition Procedure. The countries involved in the Mutual Recognition Procedure included the United Kingdom, which acted as the reference Member State, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain. The data also will be reviewed for approval nationally in other European Union member states.

About Nasal Polyps

Nasal polyps often appear in the mucous lining of the nose or in the sinuses. When inflammation in the nose occurs, blood vessels may become porous, which allows water to accumulate in the cells. Polyps develop and grow as fluid builds in the tissue.

The prevalence of nasal polyps increases with age and the condition affects up to 2- to- 4 percent of people in the United States.(2) The exact cause of nasal polyps is unknown. Nasal polyps often are seen in people with asthma. Approximately 13 percent of people with nonallergic asthma develop nasal polyps.(3) Symptoms of nasal polyps include long-term nasal congestion, diminished sense of smell, runny nose, chronic sinus infections, headaches or snoring. When polyps obstruct the nasal cavity, mucus is unable to drain properly. Surgical removal is commonly used as a last resort.

About NASONEX

Originally approved in 1997, 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) As a result of today's approval, NASONEX also is indicated for the treatment of nasal polyps in adults 18 years of age and older. NASONEX is a nasal inhaled steroid related to cortisol, a hormone produced naturally by the body, and when used as directed is safe and nonsedating. NASONEX reduces nasal congestion caused by an allergic reaction. NASONEX provides relief from the nasal 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. Visit http://www.NASONEX.com for full prescribing information and for more information on treating nasal allergies and polyps. For additional important safety information, full prescribing information also 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.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements within the meaning of the Securities Litigation Reform Act of 1995, including the market for drugs to treat nasal polyps and NASONEX's market potential. Forward-looking statements relate to expectations or forecasts of future events and use words such as "may" and "will." 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, regulations impacting pricing of pharmaceutical products, matters impacting patents on Schering-Plough products, competitive pressures including the introduction of generic products, manufacturing issues, and the regulatory process for new products and new indications. 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. Mygrind N., Dahl R., Rachert C. Nasal polyposis, eosinophil dominated inflammation, and allergy. Thorax. 2000;5S(Suppl 2):S79-S83.
3. Grigoreas C., et.al. "Nasal polyps in patients with rhinitis and asthma." Allergy Asthma Proc. 2002 May-Jun;23(3):169-74.
Media: Mary-Frances Faraji, +1-908-298-7109, or Julie Lux,
1-908-298-4774, Investor: Janet Barth, or Alex Kelly, +1-908-298-7436, all of Schering-Plough Corporation

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