Alcon amends NDA for Patanase

Switzerland-headquartered eye care firm Alcon (which is majority-owned by Swiss food giant Nestle) has submitted an amendment to its pending New Drug Application for Patanase (olopatadine HCl) nasal spray to the US Food and Drug Administration. The NDA is for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents aged 12 years and older. The amendment includes interim six-month data from an agreed-upon study previously requested by the FDA to support a modification of the formulation of the nasal spray.

"I am happy to see that Patanase is moving forward to FDA review because I believe it will provide an attractive treatment option for patients with seasonal allergic rhinitis," said Rohit Katial, a principal investigator for the product and associate professor of medicine at the National Jewish Medical and Research Center, Denver, Colorado, USA. "Data collected through multiple studies that make up the current NDA demonstrate that Patanase provides rapid relief from bothersome nasal allergy symptoms," he added.

The active ingredient in Patanase, olopatadine, is the same as that used in Alcon's market-leading family of products for ocular allergies, which includes Pataday ophthalmic solution and Patanol ophthalmic solution.