FDA approves Meda's ASTEPRO Nasal Spray

Sep 2 2009

Meda Pharmaceuticals Inc. today announced that the US Food and Drug Administration (FDA) has approved ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, for the treatment of the symptoms of seasonal and perennial allergic rhinitis (SAR and PAR). New ASTEPRO Nasal Spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. ASTEPRO Nasal Spray 0.15% relieves rhinitis symptoms, including nasal congestion, without an added decongestant such as pseudoephedrine and is formulated with azelastine, a leading nasal antihistamine in the treatment of seasonal rhinitis in the U.S. The product will be available in pharmacies in early October.

Approximately 40 million people in the U.S. suffer from seasonal and perennial allergic rhinitis. Seasonal allergic rhinitis occurs during a specific season, commonly in the fall and spring, and is caused by outdoor allergy triggers such as tree, grass or ragweed pollen. Perennial allergic rhinitis occurs throughout the year and is typically caused by indoor allergens such as dust mites, mold and animal dander. Symptoms of allergic rhinitis, or hay fever, frequently include nasal congestion, runny nose, sneezing, nose and itching.

"Seasonal and perennial allergy sufferers may benefit from ASTEPRO nasal spray 0.15%, which is 50 percent more concentrated than original ASTEPRO and offers convenient once- or twice-daily dosing for SAR. It provides fast-acting relief and is applied right at the site - in the nasal passage - to treat a broad spectrum of nasal symptoms, including congestion, caused by indoor and outdoor allergies," said William Berger, M.D., Clinical Professor, Division of Allergy and Immunology, University of California. "Based on demonstrated improvement in nasal allergy symptoms, ASTEPRO 0.15% is a good first-line therapy option for seasonal and perennial allergic rhinitis patients suffering with nasal symptoms."

"The approval of ASTEPRO Nasal Spray 0.15% represents a significant milestone for Meda as we continue to expand and strengthen our allergy treatment franchise," said Sharon Clarke, President and General Manager, Meda Pharmaceuticals Inc. "We are proud to introduce the first nasal antihistamine indicated for PAR and SAR with BID and QD dosing to the US market. We believe ASTEPRO Nasal Spray 0.15% can simplify the physician's treatment decision for patients with seasonal and perennial allergic rhinitis, and help patients who want rapid nasal symptom relief."

Source: http://www.meda.se