FDA approves Alcon’s Patanase for nasal allergy symptoms

4/16/2008

HUENENBERG, Switzerland Alcon announced that the Food and Drug Administration has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

“We look forward to providing doctors the opportunity to prescribe Patanase to their patients who need and want a fast-acting nasal spray that quickly relieves symptoms,” said Kevin Buehler, Alcon’s senior vice president of global markets and chief marketing officer. “We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise.”

Clinical studies found that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in symptoms compared to the placebo nasal spray. Additionally, onset of action was evaluated in three studies, in which patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either Patanase or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Patanase nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of affect after dosing, which was statistically significant compared to the placebo spray.

“For patients who suffer every allergy season with symptoms that make life in those months miserable, Patanase offers relief beginning in minutes in a convenient steroid-free nasal spray,” said one study’s lead investigator, Eli Meltzer. “The fact that it works quickly is important. Patients in our fast-paced society want rapid improvement and relief from their nasal allergies.”

Patanase nasal spray, an extension to Alcon’s market-leading ocular allergy product line, will be available in May of this year.

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