FDA approves Astepro nasal spray 0.15% for the treatment of the symptoms of seasonal allergies

Sep 2 2009

Meda AB (STO:MEDAA)

The U.S. Food and Drug Administration (FDA) has approved Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. This new Astepro nasal spray 0.15% (“Astepro Once-Daily”) is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. Astepro Once-Daily is formulated with azelastine, a leading nasal antihistamine in the treatment of rhinitis in the U.S. ”The approval of Astepro Once-Daily represents a significant milestone for Meda as we continue to expand our allergy treatment franchise,” said Anders Lönner, CEO Meda. “We are proud to introduce the first nasal antihistamine with once-daily dosing to the U.S. The launch is anticipated to begin in October 2009.”

The FDA approval was based primarily on the results of seven double-blind, placebo-controlled Phase III clinical trials, and a long-term, 12-month safety trial, conducted in more than 2,300 patients with seasonal and perennial allergic rhinitis.