Nasonex now FDA-approved in United States for nasal polyps
Nasonex now FDA-approved in United States for nasal polyps
KENILWORTH, N.J., December 15/ -- Schering-Plough Corporation announced that the FDA has approved Nasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg for the treatment of nasal polyps in patients 18 years of age and older. 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.
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. 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. 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.
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. As a result of this latest 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 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: www.spfiles.com/piNasonex.pdf.
Source: Schering-Plough
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