Schering-Plough's Nasonex spray shrinks nasal polyps, study says

By Angela McDaniels

Seattle, Dec. 13 - Schering-Plough Corp. said study results show that once- or twice-daily use of 50 mcg of Nasonex (mometasone furoate monohydrate) Nasal Spray is effective and safe for the treatment of nasal polyps.

Nasonex also produced significantly greater reductions in the primary endpoints of nasal congestion and nasal polyp grade compared to placebo, the company said.

"Reducing the size of nasal polyps can be a slow process; hence the improvement seen over four months is noteworthy," said Robert J. Spiegel, chief medical officer and senior vice president of Schering-Plough, in a company news release.

The study results were authored by Michael Blaiss of the University of Tennessee and published in the December issue of the Journal of Allergy and Clinical Immunology.

In the study, 354 patients were randomized to receive Nasonex 200 mcg once-daily in the morning with matching placebo in the evening, 200 mcg twice-daily in the morning and evening or placebo.

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.

Patients evaluated their symptoms, such as nasal congestion/obstruction, loss of sense of smell, anterior rhinorrhea and postnasal drip, each morning immediately before dosing.

A total of 305 patients completed the four-month treatment period. Greater reductions in bilateral polyp grade scores were observed with Nasonex 200 mcg once daily (1.15 points) and Nasonex 200 mcg twice daily (0.96 points) compared with placebo (0.50 points) at the endpoint, the company said.

Significantly greater reductions in nasal congestion/obstruction score were observed with Nasonex 200 mcg once daily (-0.47 change from baseline) or twice daily (-0.61 change) compared with placebo (-.24 change) over the one-month study interval used for this endpoint.

Treatment with Nasonex was well tolerated, with no unusual or unexpected events, the company said.

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, the company said.

Nasonex was approved by the Food and Drug Administration in December 2004 and though the European Union's Mutual Recognition Procedure in November 2004 for the treatment of nasal polyp. It is the first and only intranasal corticosteroid indicated for the treatment of nasal polyps in the United States, the company said.

Schering-Plough is a health care company based in Kenilworth, N.J., that develops prescription, consumer and animal health products.

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