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Alcon's nasal spray approved for seasonal allergic rhinitis
Wednesday, April 16 2008 | Comments
What's This?
The Food and Drug Administration approved Alcon Inc.'s Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients aged 12 years or older.The approval was based primarily on multiple clinical studies that evaluated the safety, efficacy and onset of action of the nasal spray in patients with seasonal allergic rhinitis. Two-week, randomized, double-blind clinical trials were conducted to determine the ability of Patanase to relieve allergy symptoms based on total nasal symptom scores (TNSS).
The results from these studies showed that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in TNSS as compared with those treated with the placebo nasal spray.
In addition, three environmental exposure unit studies evaluated onset of action by exposing patients with seasonal allergic rhinitis to high levels of pollen and then treating them with either Patanase or placebo nasal spray, two sprays in each nostril. After the treatment, patients self-reported their allergy symptoms hourly for the subsequent 12 hours.
Onset of action for the spray was found to be 30 minutes with a 12-hour duration of effect after dosing, which was a statistically significant result as compared with the placebo spray.
Alcon said the nasal spray should be available by May.
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