HUENENBERG, Switzerland -- April 16, 2008 -- The US Food and Drug Administration (FDA) has approved olopatadine hydrochloride (Patanase) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
FDA approval of olopatadine hydrochloride nasal spray was based primarily on multiple clinical studies for the evaluation of safety, efficacy, and onset of action. The studies were 2-week, randomised, double-blind clinical trials among patients with seasonal allergic rhinitis and were conducted to determine the efficacy of olopatadine in relieving allergy symptoms based on the total nasal symptom score (TNSS). The studies found that patients treated with olopatadine nasal spray -- 2 sprays per nostril twice daily -- demonstrated significantly greater decreases in TNSS compared with the placebo nasal spray.
Additionally, onset of action was evaluated in 3 environmental exposure unit studies. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen and then were treated with either olopatadine or placebo nasal spray -- 2 sprays in each nostril -- after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. According to these patient reports, 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.
"For patients who suffer every allergy season with symptoms that make life in those months miserable, [olopatadine] offers relief beginning in minutes in a convenient steroid-free nasal spray," said Eli Meltzer, MD, Co-Director, Allergy and Asthma Medical Group and Research Center, San Diego, California, and lead investigator on one study submitted to the FDA. "The fact that it works quickly is important. Patients in our fast-paced society want rapid improvement and relief from their nasal allergies."
SOURCE: Alcon, Inc.
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