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Title: Nasonex (Mometasone Furoate Monohydrate) Approved by Health Canada for Nasal Polyps

"Nasonex (Mometasone Furoate Monohydrate) Approved by Health Canada for Nasal Polyps"

#1 Patient-preferred Nasal Inhaled Corticosteroid now also treats Polyposis POINTE-CLAIRE, QC, CANADA -- December 6, 2006 -- Schering Canada announced that Nasonex® (mometasone furoate monohydrate) has been approved by Health Canada for the treatment of nasal polyps, also known as polyposis, in adults (including geriatric patients) and adolescents 18 years of age and older. Nasonex provides patients with an effective alternative to surgery, which does not always prevent recurrence. The approval of Nasonex for the treatment of nasal polyps makes it the nasal inhaled corticosteroid with the widest range of indications including allergic rhinitis (seasonal and perennial allergies), acute sinusitis (as an adjunctive treatment to antibiotics) and now polyposis. The removal of phenylethyl alcohol has resulted in the recent launch of scent-free Nasonex. This new and improved formulation, now available in Canada, offers powerful efficacy for more patients, as patients have indicated a preference for a scent-free product. "Patients suffering from polyposis now have another approved treatment option other than surgery, which has inherent risks and complications and certainly does not always prevent recurrence," said Dr. Peter Spafford, a leading otolaryngologist (ear, nose and throat specialist) at the Royal University Hospital in Saskatoon. "The approval of Nasonex for the treatment of nasal polyps provides patients with a proven effective treatment that delivers medicine directly to the target area. Nasonex reduces nasal polyps and relieves symptoms, including congestion." Caused by chronic inflammation in the lining of the nose and sinuses, nasal polyps are grape-like growths in the nasal cavity. Polyps occur when the nasal mucous membranes swell and produce excess fluid in the nasal cells[viii]. Polyps reduce airflow in the nasal passages, leading to congestion[ix]. Small nasal polyps usually cause few problems, but larger ones can affect breathing and diminish sense of smell[x]. They may cause dull headaches or snoring, and in rare cases, massive polyps can alter the shape of the face[xi]. The overall prevalence rate of nasal polyposis in the general population is estimated to be approximately two to four per cent[xii],[xiii],[xiv]. Although nasal polyps can affect anyone, they're more common in people older than 40, and in adults and children with conditions such as asthma, chronic sinus infections, seasonal allergies (hay fever) and cystic fibrosis.[xv] Basis for Approval[xvi],[xvii] In two controlled clinical trials involving 664 patients 18 to 86 years of age with nasal polyposis, Nasonex showed significant improvement when compared to placebo in the clinically relevant endpoints of congestion, and nasal polyp size. 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 may be effective for continued treatment, once the symptoms have been controlled. About Nasonex Nasonex is a nasal inhaled corticosteroid related to cortisol, a hormone produced naturally by the body, and when used as directed, is safe, non-sedating and not addictive[xviii]. As a pharmaceutical preparation that contains no phenylethyl alcohol, Nasonex is also alcohol-free and scent-free. Originally approved in Canada in 1998, Nasonex is now also indicated for the treatment of nasal polyps in patients 18 years and older, as well as for use in adults, adolescents, and children between the ages of three and 11 years to treat the symptoms of seasonal or perennial allergic rhinitis. Nasonex is also approved by Health Canada for the treatment of acute episodes of sinusitis, as adjunctive treatment to antibiotics, for use in adults and children 12 years of age and older. REFERENCES: [i] Nasonex® Product Information. Schering-Plough Corporation. [ii] http://www.rxmed.com./b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [iii] Settipane GA. Nasal polyps: pathology, immunology, and treatment. Am J Rhinol 1977;15:121-8. [iv] Van der Baan B. Epidemiology and natural history, In: Mygind N, Lildholdt T, cds. Nasal polyposis: an inflammatory disease and its treatment. Copenhagen; Munksgaard, 1997; 13-6. [v] Hedman J, Kaprio J, Poussa T, et al. Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study. Ins J Epidemiol 1999;28:717-22. [vi] http://www.healthline.com/adamcontent/nasal-polyps [vii] http://www.healthline.com/adamcontent/nasal-polyps [viii] http://www.rxmed.com./b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [ix] http://www.rxmed.com./b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [x] MayoClinic.com http://www.rxmed.com/b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [xi] MayoClinic.com http://www.rxmed.com/b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [xii] Settipane GA. Nasal polyps: pathology, immunology, and treatment. Am J Rhinol 1977;15:121-8. [xiii] Van der Baan B. Epidemiology and natural history, In: Mygind N, Lildholdt T, cds. Nasal polyposis: an inflammatory disease and its treatment. Copenhagen; Munksgaard, 1997; 13-6. [xiv] Hedman J, Kaprio J, Poussa T, et al. Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study. Ins J Epidemiol 1999;28:717-22. [xv] MayoClinic.com http://www.rxmed.com/b.main/b1.illness/b1.1.illnesses/Polyps,%20nasal.html [xvi] Nasonex Product Monograph – October 2006 [xvii] http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=655241 [xviii] Nasonex® Product Information. Schering-Plough. SOURCE: Schering Canada

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