Newly Analyzed Data Show Daily Treatment With Nasonex Significantly Reduces Symptom Recurrence In Patients With Perennial Allergic Rhinitis
Warsaw, Poland – June 9, 2009 – Recently analyzed data demonstrate the benefits of adhering to a daily NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg* treatment regimen following initial symptom relief, including longer sustained relief of nasal symptoms and significantly fewer recurrences, compared with placebo. Results from this post hoc analysis of four Phase III clinical studies of adult patients with perennial allergic rhinitis (PAR) were presented today for the first time at the Congress of the European Academy of Allergology and Clinical Immunology, held in Warsaw, Poland, June 6-10, 2009.
“It is common for allergic rhinitis patients to stop taking their allergy medications after achieving initial symptom relief,” said Peter Clement, M.D., Department of Otorhinolaryngology, University Hospital, Free University of Brussels. “This analysis is important because it reinforces the need for patients to adhere to a daily allergy treatment regimen, even after experiencing initial symptom relief, to help stop symptoms from coming back.”
Allergic rhinitis affects approximately one in four Europeans.1 Symptoms, which may include sneezing, congestion, itchy and runny nose, and itchy, redness or watery eyes,2 can have an impact on everyday activities at work, school and leisure time, as well as disturbed sleep.2 There also is a growing body of evidence that points to an association between allergies and other respiratory conditions, such as asthma.2
The primary endpoint of this analysis was the mean change from baseline in daily individual nasal symptoms (congestion, itching, sneezing, rhinorrhea). To evaluate the effectiveness of NASONEX for the sustained relief of perennial nasal allergy symptoms, researchers retrospectively analyzed pooled data from four randomized, double-blind, placebo-controlled, Phase III clinical studies of 1,297 patients, 12 years of age and older, with at least a two-year history of perennial allergic rhinitis (PAR) and symptomatic at baseline. Patients were randomized to once-daily treatment with NASONEX (n=650) or placebo (n=647) for 12 weeks. Individual nasal symptoms were scored daily on a 4-point scale (0=none; 3=severe). Symptom suppression was defined as at least a 75% decrease in total nasal symptom score (TNSS) from baseline; symptom recurrence was defined as a return to TNSS of at least 50% of baseline after initial suppression; and days with minimal symptoms (DMS) as all individual symptom scores of 1 or less and TNSS of 2 or less. Mean baseline TNSS was similar between groups (NASONEX=6.33; placebo=6.27).
A significantly greater percentage of patients receiving NASONEX than placebo achieved symptom suppression 422 (64.9%) vs. 344 (51.6%; p<0.001). NASONEX demonstrated significantly shorter mean time to suppression (28 days vs. 58 days; p<0.001) and significantly longer mean time to recurrence (8 days vs. 5 days; p<0.001) compared with placebo. Significantly fewer NASONEX than placebo subjects reported recurrence of symptoms at 30 days (72.3% vs. 81.1%; p=0.005) and 60 days (78.7% vs. 85.3%; p=0.019). Following initial suppression, treatment with NASONEX resulted in significantly higher proportion of DMS (73%) vs. placebo (53%; p<0.0001).
NASONEX provides relief from symptoms of seasonal and perennial allergic rhinitis, including nasal congestion, sneezing and an itchy, runny nose, and itchy, red and teary eyes. NASONEX is safe, nonsedating and not addictive when used as directed. Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds and coughing. NASONEX builds upon Schering-Plough’s heritage as a leader in discovery and development. Products from the company’s research efforts include the CLARITYN® (loratadine) family of nonsedating antihistamines and AERIUS® [NEOCLARITYN®] (desloratadine) syrup and tablet.
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
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1. Dahl R, Anderson PS, Chiavto T, Valovirta E, de Monchy J. National prevalence of respiratory allergic disorders. Resp Med 2004; 98: 398-403.
2. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001.
Posted: June 2009