The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray.
The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S.
Astepro is now approved for treatment of seasonal allergic rhinitis. Fewer reports of bitter taste and nasal discomfort were recorded by Astepro users and it was in general better tolerated than Astelin. Symptom relief, as recorded by patients, was also better. In total, about 1,400 patients were involved in Meda's phase III studies.
"Our development team has done an excellent work answering the questions from FDA and reaching approval in such a short time. This is an important milestone for Meda", said Anders Lönner, CEO Meda.
Full launch of Astepro in the U.S. will take place well before the next allergic rhinitis season.