KENILWORTH, N.J., Nov. 8 /PRNewswire/ -- More than 80 percent of people with allergic rhinitis experience symptoms in the morning and approximately half indicate symptoms are most severe in the morning, particularly when they first awake, according to a national survey presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Anaheim, Calif.
“Most of my patients say the morning is the toughest time of the day to control allergy symptoms,” said Michael Blaiss, M.D., Clinical Professor of Pediatrics and Medicine, University of Tennessee and immediate past President of ACAAI. “These survey results validate what physicians have been hearing from patients, that it is crucial to relieve morning allergy symptoms.”
Not surprisingly, more than 90 percent of those surveyed said it is important for an allergy medication to help them wake up with symptoms under control.
An estimated 36 million Americans are affected by allergic rhinitis symptoms, which can be caused seasonally by pollen, or perennially as a result of dust mites, pet dander or mold.(1) One in every five adults and approximately 40 percent of children are affected by allergic rhinitis,(1) which is responsible for six million lost work days and two million lost school days in the U.S. each year.(2)
According to a clinical study presented at the meeting, CLARINEX(R) (desloratadine) significantly reduces morning symptoms of seasonal allergic rhinitis (SAR). The double-blind, placebo-controlled study of 534 patients assessed the effectiveness of CLARINEX in relieving symptoms of SAR and an analysis of morning symptom scores, which reflect symptoms 24 hours after the last dose of treatment. The research found significant improvements for patients receiving CLARINEX compared to those receiving placebo.
“In the study, patients taking once-daily desloratadine experienced relief of symptoms in the morning, starting with the first measured time period, 24 hours after the first dose, and also reported sustained improvements for the full 24-hour dosing period,” said Catherine Neukirch, M.D., Pulmonology and Allergology Dept. of Hopital Bichat, Paris, France and lead researcher.
CLARINEX is a nonsedating prescription antihistamine that provides 24-hour relief of allergic rhinitis symptoms in adults and children. CLARINEX is available as a regular tablet, an orally-disintegrating tablet, CLARINEX RediTabs(R), as bubblegum-flavored syrup for children as young as 6 months, and in combination with a decongestant, CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets for patients 12 years of age and older. CLARINEX is marketed in Europe under the trade names AERIUS(TM) and NEOCLARITYN(TM).
About the Survey
The online survey of 1,000 adults 18 years of age and older who had a medical diagnosis of allergies or hay fever was conducted by Roper Public Affairs in January 2005. Participants were asked about their morning symptoms. The sample was balanced to be representative of the U.S. population by ethnicity, sex and presence of children at home, based on census data. Data were weighted by gender to represent the allergy sufferer population. The sampling error margin of the total sample was +/- 3 percent.
About the Placebo-Controlled Study
In the clinical study, 534 patients aged 18 years and older, with at least a two-year history of recurrent SAR with positive skin prick test, were randomized to CLARINEX 5 mg Tablets or placebo once daily each morning for 15 days (days 014). Patients rated nasal (rhinorrhea, itching, sneezing, congestion) and non-nasal (itching ears/palate, itching/tearing/burning/ reddened eyes) symptoms daily in the morning (prior to dosing) and evening on a scale of 0 (none) to 3 (severe). Investigators and patients jointly assessed symptoms on days 0 and 14. The primary efficacy variable was change from baseline to day 14 in total nasal symptom score (TNSS; mean of a.m. and p.m. summed nasal scores).
There was a significant reduction in a.m. total symptom score with CLARINEX versus placebo at day 1, 24 hours after the first dose (P=0.04). CLARINEX also was significantly superior to placebo for the primary endpoint (change in TNSS at day 14 of -4.22 for CLARINEX versus -3.08 for placebo; P=0.0003). CLARINEX was well tolerated and side effects were similar to placebo.
About Allergic Rhinitis
Allergic rhinitis encompasses the outdoor symptoms of seasonal allergic rhinitis (SAR) and the indoor symptoms of perennial allergic rhinitis (PAR). An estimated 40 to 50 percent of people with allergies are believed to suffer from both SAR and PAR; 20 to 30 percent from SAR alone; and 15 to 30 percent from PAR alone.(3) Nasal allergy symptoms, which classically include sneezing, itching, nasal discharge, and congestion, can have a significant impact on everyday activities at work, school and leisure time.
In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions such as asthma.(4)
About the CLARINEX Family of Products
CLARINEX is a long acting antihistamine with a 27-hour half life. CLARINEX (5 mg) Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX (2.5 and 5 mg orally-disintegrating tablets) RediTabs(R) tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older. CLARINEX (0.5 mg per 1 mL) Syrup, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children 2 years of age and older, and indoor allergies and hives of unknown cause in children as young as 6 months. CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/ pseudoephedrine 240 mg) Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.(5)
Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue. Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.(5)
Due to its pseudoephedrine component, CLARINEX-D 24 HOUR Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past 14 days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their health care provider before taking CLARINEX-D 24 HOUR Extended Release Tablets. Care should be used if CLARINEX-D 24 HOUR Extended Release Tablets is taken with other antihistamines or decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 24 HOUR Extended Release Tablets were dry mouth, headache, insomnia, fatigue, sore throat and drowsiness.(5)
Visit www.CLARINEX.com for more information on treating allergic rhinitis. For additional important product information, full prescribing information is available at: http://www.spfiles.com/piclarinex.pdf.
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements related to CLARINEX and the potential market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statements. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these or other factors that may impact the forward- looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including the company’s third quarter 2005 10-Q.
References: 1. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000. 2. deShazo RD. Allergic rhinitis. Cecil Textbook of Medicine. 21st edition. St. Louis. W.B. Saunders Company; 2000: 1445-1450. 3. (C) Decision Resources, Inc. 4. Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study,. Allergy 2002; 57: 1048-52. 5. CLARINEX(R) Product Information. Schering Corporation.
Schering-Plough Corporation
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