The FDA has approved Astepro (azelastine HCl nasal spray, from Meda) 0.15%, a nasal antihistamine, for the relief of symptoms associated with seasonal and perennial allergic rhinitis in patients ≥12 years of age. This approval was based on data from seven Phase 3, double-blind, placebo-controlled clinical trials of 2–4 weeks duration, and a long-term, 12-month safety trial conducted in more than 2,300 patients with season or perennial allergic rhinitis. Results from the 2–4 week trials showed that patients treated with Astepro 0.15% experienced a significant reduction in total nasal symptom scores (TNSS) (composed of nasal congestion, itchy nose, runny nose, and sneezing) over the entire study period compared to those who received placebo.
Astepro 0.15% delivers 205.5mcg azelastine per metered spray and may be dosed once daily. Astepro is already available in a 0.1% strength formulation which delivers 137mcg azelastine per metered spray.
For more information call (732) 564-2200 or visit www.astepro.com.