Schering-Plough Corporation received an approval from the US Food and Drug Administration for Clarinex-D 12 hour (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) extended release tablets for the relief of nasal and non- nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.
Clarinex-D 12 hour will be available in the US in March 2006, in time for the spring allergy season. The new treatment option addresses an important need for allergy sufferers, who indicate that nasal congestion is the most bothersome symptom of allergic rhinitis, states a Schering Plough release.
In addition, a survey of 1,000 adults with allergic rhinitis found nearly 85 per cent experience nasal congestion when they first wake up, making it the most prevalent allergy symptom in the morning.
The new formulation uses a bi-layer tablet delivery system, which controls the release of the pseudoephedrine component for consistent delivery. The recommended twice-daily dosing of Clarinex-D 12 hour will help patients control their nasal congestion, along with their sneezing, runny nose, itchy throat, or itchy and watery eyes, in the morning and throughout the day.
"Physicians now have a 12-hour formulation that combines the proven efficacy and safety of Clarinex with an established decongestant. Clarinex-D 12 hour provides physicians with another option for tailoring allergy treatment regimens based on patients' specific symptoms and needs," said Robert J. Spiegel, chief medical officer and senior vice president, Schering-Plough.
The FDA approved Clarinex-D 12 hour based on results from two clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Clarinex-D 12 hour. In both 2-week randomised, parallel group trials, the antihistaminic efficacy of Clarinex-D 12 hour, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than that of pseudoephedrine alone during the treatment period. And the decongestant efficacy of Clarinex-D 12 hour was significantly greater than that of desloratadine alone during the treatment period, based on nasal congestion scores. As the data show, Clarinex-D 12 hour effectively treats nasal congestion, the most bothersome symptom of allergic rhinitis, in addition to relieving other nasal and non-nasal symptoms of allergic rhinitis, added the release.
Seasonal allergies affect an estimated 36 million people in the US. Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time.
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.