Alcon Inc.'s olopatadine HCl nasal spray (Patanase) has been approved by the FDA for the relief of the symptoms of seasonal allergic rhinitis in patients aged 12 or more years, the company announced.
Huenenberg, Switzerland-Alcon Inc.'s olopatadine HCl nasal spray (Patanase) has been approved by the FDA for the relief of the symptoms of seasonal allergic rhinitis in patients aged 12 or more years, the company announced.
The approval primarily was based on multiple clinical studies for the evaluation of safety, efficacy, and onset of action. The studies were 2-week, randomized, double-blind clinical trials in patients with seasonal allergic rhinitis and were conducted to determine the ability of the spray to relieve allergy symptoms based on total nasal symptom scores (TNSS), a composite of stuffy, runny, itchy nose and sneezing. The results of these clinical studies were that patients treated with olopatadine, two sprays per nostril, twice daily, demonstrated significantly greater decreases in TNSS compared with the placebo nasal spray.
Additionally, onset of action was evaluated in three environmental exposure unit studies. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either olopatadine or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Olopatadine nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of effect after dosing, which was statistically significant compared with the placebo spray.