KENILWORTH, N.J., Dec. 13 /PRNewswire-FirstCall/ -- Results of a new study published in the December issue of the Journal of Allergy and Clinical Immunology concluded once- or twice-daily use of NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg* is effective and safe for the treatment of nasal polyps. The 4-month study also showed treatment with NASONEX produced significantly greater reductions in the co-primary endpoints of nasal congestion and nasal polyp grade compared to placebo.
Nasal polyps are growths in the nasal cavity that can reduce airflow in the nasal passages, leading to nasal congestion, rhinorrhea, postnasal drip and loss of smell. If unresolved, surgery may be needed to remove the nasal polyps and restore airflow in the nasal passages.
“In the study, both once- and twice-daily doses of NASONEX provided significant improvements in polyp grade, as well as relief of nasal congestion, compared to placebo,” said Catherine B. Small, M.D. of New York Medical College and lead author of the study. “Treatment with NASONEX is a useful management approach for patients with nasal polyps.”
The December issue of the publication also featured an editorial, which reviewed the data and evaluated the applicability of the research in clinical practice.
“This is the largest controlled study of its kind to be carried out to date,” said Michael Blaiss, M.D. Clinical Professor of Pediatrics and Medicine, University of Tennessee and author of the editorial. “The data strongly suggest that mometasone furoate is an effective medical treatment, in terms of reducing polyp size and grade and improving symptoms, and further validates first-line use of medical therapy in this condition. “NASONEX was approved by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of nasal polyps in patients 18 years of age and older.(1) Available in a scent-free, alcohol-free formulation, NASONEX is the first and only intranasal corticosteroid indicated for the treatment of nasal polyps in the U.S.
“Reducing the size of nasal polyps can be a slow process; hence the improvement seen over four months is noteworthy,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough. “In addition to the efficacy demonstrated in both NASONEX study groups, the treatment was well-tolerated and adverse events were similar to placebo.”
NASONEX also is the only once-daily prescription intranasal corticosteroid 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 intranasal corticosteroid approved to treat nasal allergy symptoms, including nasal congestion, in patients as young as 2 years of age.(1)
In November 2004, 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 are the United Kingdom, which acted as the Reference Member State, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain. In addition, NASONEX received approval for nasal polyps in France (February 2005) and Sweden (May 2005).
About the Study
In this placebo-controlled study, 354 patients 18 years of age and older were randomized to receive NASONEX 200 mcg once-daily (QD) in the morning with matching placebo in the evening, 200 mcg twice-daily (BID) in the morning and evening, or placebo BID. An endoscopy was performed by the investigator before treatment and at monthly visits during treatment. Nasal polyps were graded by size and extent on a scale of 0 to 3. The sum of the right and left nasal polyp score provided the total bilateral polyp grade (0 to 6). Patients evaluated their symptoms (nasal congestion/obstruction, loss of sense of smell, anterior rhinorrhea, and postnasal drip) each morning, immediately before dosing.
A total of 305 patients (86 percent) completed the 4-month treatment period, with a greater proportion of placebo recipients discontinuing the treatment phase (19 percent) compared to NASONEX recipients (12 percent of QD treatment group; 11 percent of BID group). Greater reductions in bilateral polyp grade scores were observed with NASONEX 200 mcg QD (1.15 points; P less than or equal to 0.001) and NASONEX 200 mcg BID (0.96 points; P = 0.010) compared with placebo (0.50 points) at the endpoint.
Significantly greater reductions in nasal congestion/obstruction score were observed with NASONEX 200 mcg QD (-0.47 change from baseline; P=0.001) or BID (-0.61 change from baseline; P < 0.001) compared with placebo (-.24 change from baseline) over the 1-month study interval used for this endpoint.
Treatment with NASONEX was well tolerated, with no unusual or unexpected events. The overall incidence of adverse events related, the majority of which were consider unlikely related to the study drug, was similar among all three treatment groups. The most common adverse events considered to be possibly related to treatment were epistaxis (defined to include a wide range of bleeding episodes), headache, nasal dryness and nasal irritation.
About Nasal Polyps
Nasal polyps often appear in the mucous lining of the nose. 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 two to four percent of the general population.(2) Nasal polyps are often seen in people with chronic rhinosinusitis, but the exact cause of nasal polyps is unknown. In addition, 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, headaches or snoring. When polyps obstruct the nasal cavity, mucus is unable to drain properly. Surgical removal is commonly used as a last resort, although polyps may still reappear.
About NASONEX
Originally approved in 1997, NASONEX is an intranasal corticosteroid 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, 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 and is approved for the treatment of nasal polyps. 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 helping prevent 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, CLARINEX(R) (desloratadine) tablets, syrup and RediTabs(R) and CLARINEX-D(R) 24 HOUR (desloratadine 5mg/pseudoephedrine sulfate USP 240 mg) Extended Release Tablets.
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. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
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. 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 2005 third quarter 10-Q.
(1) NASONEX(R) Product Information. Schering Corporation. (2) Mygrind N., Dahl R., Bachert 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. *Calculated on the anhydrous basis.
Schering-Plough Corporation
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