US approval for OTC use of Bayer’s Astepro

The US Food and Drug Administration (FDA) has approved Bayer’s steroid-free antihistamine nasal spray Astepro for over-the-counter use.

Astepro (azelastine HCI .15%) will now be available in the US as an OTC product for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies.

Following the FDA approval, Astepro becomes the first and only OTC steroid free antihistamine nasal spray available in the US for adults and children aged six years and older.

The OTC formulation is full prescription strength – in a statement, Bayer said the nasal spray includes a number of benefits, including flexible dosing that can provide up to 24-hour relief of nasal congestion, running nose, sneezing and itchy nose from indoor and outdoor allergies.

“At Bayer, we help make self-care a reality for billions through everyday healthcare. This new differentiated product is one step in that direction, with the potential to help millions of people in the U.S. that suffer from seasonal allergic rhinitis,” said Catherine Vennat, VP/GM Bayer Consumer Health US.

“With Astepro Allergy, allergy sufferers can get relief of allergy nasal symptoms in an over-the-counter treatment option without steroids or decongestants that will last up to 24-hours. It will bring a crucial differentiated allergy product to the Bayer allergy portfolio to address unmet consumer needs with allergic rhinitis,” she added.

Astepro will not immediately become available to patients, with Bayer adding in a statement that the treatment will become available at national mass retail locations in the first quarter of 2022.