New Analyses Show Nasonex Is More Effective Than Loratadine For The Treatment Of Nasal Allergy Symptoms And At Least Comparable For Ocular Symptoms
Warsaw, Poland – June 9, 2009 – According to new data presented today for the first time, patients with seasonal allergic rhinitis (SAR) experienced greater relief of nasal symptoms and equivalent relief of ocular symptoms with NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg* versus the antihistamine loratadine. Results were presented at the Congress of the European Academy of Allergology and Clinical Immunology, held in Warsaw, Poland, June 6-10, 2009.
Researchers retrospectively analyzed data from a 15-day, Phase III clinical trial of patients age 12 and older with SAR. NASONEX demonstrated greater efficacy than loratadine for individual nasal symptoms (congestion, rhinorrhea, sneezing and itching) and total nasal symptoms. Loratadine offered no significant advantage against individual ocular symptoms (tearing, redness and itching) or total ocular symptoms.
“This analysis is important because it demonstrates that NASONEX can be used as a single therapy for the treatment of both nasal and ocular symptoms of seasonal allergies, providing health care professionals with a proven treatment option for their patients,” said Robert Nathan, M.D., University of Colorado Health Sciences Center, Denver, CO. “These results back up clinical studies we’ve seen with similar findings and add additional support to current ARIA guidelines recommending intranasal corticosteroids as a first-line treatment for allergic rhinitis, especially when nasal congestion is present.”
About the Analysis
To compare the efficacy of NASONEX to loratadine, researchers retrospectively analyzed data from a randomized, double-blind, Phase III clinical trial in which subjects with SAR, 12 years of age and older, received NASONEX (n=166) or loratadine (n=174) for 15 days. Subjects scored individual nasal and ocular symptoms in diaries twice daily on a scale of 0 (none) to 3 (severe). The primary endpoint of the analysis was the mean change from baseline over Days 1-15 for total nasal symptom scores (TNSS), total ocular symptom scores (TOSS), and individual nasal and ocular scores.
Analysis Results
For TNSS, the mean change from baseline over Days 1-15 was significantly greater for NASONEX (-2.71) versus loratadine (-1.93, P=0.002), with NASONEX demonstrating superiority by Day 3. Change in congestion from baseline over Days 1-15 was -0.67 for NASONEX versus -0.44 for loratadine (P<0.001), with NASONEX demonstrating greater efficacy versus loratadine by Day 2. Improvements were also greater in the NASONEX group versus loratadine for rhinorrhea (-0.70 vs. -0.38, P<0.001) and sneezing (-0.72 vs. -0.54, P=0.016). Though there was a numerical advantage for NASONEX in nasal itching, the treatment difference between the two groups was not significant. Mean changes in TOSS and individual ocular symptoms were in slight favour of NASONEX but the treatment differences were not significant between groups.
About NASONEX
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.
# # #
