The FDA has approved Bayer’s Astepro allergy nasal spray for over-the-counter use. Bayer said the product is the first steroid-free antihistamine nasal spray for allergy relief to be authorized for OTC use in the U.S.
Meda won FDA approval for a prescription version of Astepro, a revised formulation of the azelastine active ingredient also used in Astelin, in 2008. The latest regulatory action clears Bayer to market the nasal spray on an OTC basis, potentially improving access to Astepro among the 50 million Americans who suffer from allergies.
The approval covers a product that is the same strength as the prescription product. Astepro is designed to provide up to 24 hours of relief from nasal congestion, runny nose, sneezing and itchy nose from indoor and outdoor allergies.
Bayer will miss the 2021 allergy seasons, with Astepro only scheduled to become available OTC from national mass retail locations in the first quarter of 2022. The timing of the introduction positions Bayer to offer Astepro to patients suffering from the waves of allergens that rise and fall throughout the year, starting with tree pollen in February or March.
OTC Astepro will slot into an allergy and cold consumer health unit that has suffered as a result of the pandemic. Sales fell 6.5% last year and slumped 34.9% in the first quarter. Bayer, which blamed “protective and hygiene measures and ongoing lockdowns” for the recent slump, is looking to Astepro to differentiate its portfolio.
“This new differentiated product … [has] the potential to help millions of people in the U.S. that suffer from seasonal allergic rhinitis. It will bring a crucial differentiated allergy product to the Bayer allergy portfolio to address unmet consumer needs with allergic rhinitis,” Catherine Vennat, vice president of U.S. marketing for allergy, cough and cold products, said in a statement.