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MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine
Date:9/2/2009

utes in one clinical trial and in 45 minutes in a second trial.

Once-daily or twice-daily use of ASTEPRO Nasal Spray 0.15% was generally well tolerated in the seven clinical trials. The most common adverse events when dosed two sprays per nostril (once or twice daily, respectively) for SAR and PAR included bitter taste (4 percent, 6 percent), nasal discomfort (4 percent, 3 percent), epistaxis (2 percent, 1 percent), and sneezing (1 percent, 2 percent). Overall, less than two percent of patients discontinued due to adverse reactions. Withdrawal due to adverse reactions was similar among the treatment groups. In the above trials, somnolence was reported in <1% of patients treated with ASTEPRO Nasal Spray 0.15% (11 of 1544) or vehicle placebo (1 of 1339).

In the 12-month, long-term safety trial, 466 patients (12 years of age and older) with perennial allergic rhinitis were treated with ASTEPRO Nasal Spray 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray two sprays per nostril once daily. The most frequently reported adverse reactions (>5%) with ASTEPRO Nasal Spray 0.15% were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. No patients had reports of severe epistaxis. Fifty-four patients (12%) treated with ASTEPRO Nasal Spray 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events over the course of 12 months.

About ASTEPRO

The active ingredient in ASTEPRO Nasal Spray 0.15% is azelastine - a leading nasal antihistamine in the treatment of seasonal rhinitis in the U.S. ASTEPRO Nasal Spray 0.15% is supplied as a metered-dose solution for intranasal administration. ASTEPRO 0.15% is formulated with sucralose, a non-caloric sweetener with a safety profile establishe
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SOURCE Meda Pharmaceuticals Inc.
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