"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."
FDA approval was based primarily on the results of seven double-blind, placebo-controlled Phase III clinical trials of two to four weeks duration, and a long-term, 12-month safety trial, conducted in more than 2,300 patients with seasonal or perennial allergic rhinitis. In the SAR trials, patients were treated with 2 sprays per nostril of either ASTEPRO Nasal Spray 0.15% or placebo administered once or twice daily. In the PAR trial, patients were treated with 2 sprays per nostril of either ASTEPRO Nasal Spray 0.15% or placebo administered twice daily. Overall, results from the two- to four- week clinical trials showed that patients treated with ASTEPRO Nasal Spray 0.15% experienced a significant reduction in total nasal symptom scores (TNSS) over the entire study period compared to placebo. The TNSS consists of patient rated scores of nasal congestion, itchy nose, running nose and sneezing.
ASTEPRO Nasal Spray 0.15% demonstrated a rapid onset of nasal symptom relief in as early as 30 min
|SOURCE Meda Pharmaceuticals Inc.|
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