US FDA clears Meda's new Astepro

The US Food and Drug Administration has approved Astepro, the new formulation of Swedish firm Meda's Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients. The active substance in these products is azelastine, a leading nasal antihistamine in the treatment of rhinitis in the USA.

Astepro is now approved for treatment of seasonal allergic rhinitis. Fewer reports of bitter taste and nasal discomfort were recorded by users of the new product 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 [the] FDA and reaching approval in such a short time. This is an important milestone for Meda," said Anders Lonner, chief executive of Meda.