The EC approval results in marketing authorization with unified labeling that will be valid in the 27 current EU member states as well as in Iceland and Norway. The new antihistamine with decongestant 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 Aerinaze will help patients control their nasal and non-nasal symptoms, including stuffiness/congestion, sneezing, runny or itchy nose, itching of the ears or palate, itchy and watery eyes, or redness of the eyes, in the morning and throughout the day, the company said.
The EC approved the drug based on results from a pair of two-week parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Aerinaze tablets. In both trials, the antihistaminic efficacy of Aerinaze, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than that of pseudoephedrine alone during the treatment period.
In addition, the decongestant efficacy of Aerinaze was significantly greater than that of Schering-Plough’s Clarinex (desloratadine) alone during the treatment period, based on nasal stuffiness/congestion scores. The study data show that Aerinaze effectively treats nasal congestion, in addition to relieving other nasal and non-nasal symptoms of seasonal allergic rhinitis.
The most commonly reported adverse events for Aerinaze were insomnia, dry mouth, and headache.