The approval makes Clarinex-D 24-hour (desloratadine 5mg and pseudoephedrine sulfate USP 240mg) extended release tablets available in time for the 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 product 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 approval is based on results from two two-week clinical trials involving 2,852 patients with seasonal allergic rhinitis, 708 of whom received Clarinex-D 24-hour. In both trials, the antihistaminic efficacy of Clarinex-D 24-hour, in symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than pseudoephedrine or Clarinex 5mg alone. Furthermore, the decongestant efficacy of Clarinex-D 24-hour, when measured by nasal congestion, was significantly greater than desloratadine.