The US FDA has approved Schering-Plough Corporation's Clarinex-D 24 hour (desloratadine 5mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.
Available this April in time for spring allergy season, Clarinex-D 24 hour will be the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms, the company says in a release.
"With the approval of Clarinex-D 24 hour, physicians have a once-daily prescription allergy treatment that combines the proven efficacy and safety of Clarinex with an established decongestant," said Robert J. Spiegel, chief medical officer and senior vice president, Schering-Plough.
Clarinex-D 24 hour uses a Gel Control system to control the release of the pseudoephedrine component for consistent delivery. This ensures once-daily 24-hour efficacy, which allows people to wake up with their symptoms under control.
The FDA approved Clarinex-D 24 hour based on results from two 2-week randomized, parallel group clinical trials involving 2,852 patients 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received Clarinex-D 24 hour. In both trials, the antihistaminic efficacy of Clarinex-D 24 hour, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than pseudoephedrine or Clarinex 5 mg alone during the treatment period. And the decongestant efficacy of Clarinex-D 24 hour, when measured by nasal congestion, was significantly greater than desloratadine during the treatment period, the release stated.