No more prescriptions: Bayer gets FDA nod to provide allergy nasal spray over the counter

Bayer
The FDA has approved a nonprescription version of Bayer's Astepro, making it the first over-the-counter antihistamine nasal spray for allergies. (Bayer)

Thanks to a new FDA green light, U.S. patients won't need a prescription for a nasal spray to relieve allergy symptoms—starting early next year.

Thursday, the FDA dropped the prescription requirement for Bayer’s Astepro for seasonal and year-round allergic rhinitis. It is considered a “partial switch,” because the drug’s use in children younger than six still requires a prescription.

The approval makes Astepro the first antihistamine nasal spray for allergies available over the counter in the U.S., the FDA noted. Antihistamines represent a major class of OTC allergy meds, but they’re given by mouth.

U.S. patients won’t be able to immediately get Astepro off the shelf, though; Bayer will make the drug available at national retail locations in the first quarter next year, the company said in a statement Thursday.

Astepro, or azelastine hydrochloride nasal spray, offers patients once- or twice-daily dosing and provides up to 24 hours relief of allergic symptoms such as nasal congestion, running nose and sneezing, the company said.

RELATED: GSK partners with Arthritis Foundation as it preps Voltaren for OTC switch

Making the pharmacy-to-retail switch represents a popular strategy among consumer health players. Sanofi, for example, has said it intends to sell off about 60% of its consumer health portfolio, or 150 brands, in the next few years to focus on core OTC products as well as pursuing Rx-to-OTC switches. Through a 2019 deal with Roche, Sanofi is working on nonprescription version of popular flu drug Tamiflu, and it also has OTC rights to Eli Lilly’s erectile dysfunction blockbuster, Cialis.

GlaxoSmithKline, while in the process of spinning off its consumer health business into a standalone company, won an FDA go-ahead last February for Voltaren Arthritis Pain.

RELATED: Sanofi grabs nonprescription rights to Roche's Tamiflu, aiming for Rx-to-OTC switch

As for Bayer, its consumer health business enjoyed strong growth last year, with sales of €5.05 billion ($6.0 billion), up 5.2% after adjusting for portfolio and foreign exchange rate changes. The increase was mainly thanks to the pandemic driving up demand for nutritional products. The unit’s lead allergy product, oral antihistamine Claritin, also pulled off a sales growth.

The focus at Bayer consumer health is to maintain “sustainable, profitable above-market growth at the top of our industry,” Bayer CEO Werner Baumann said in March.

Bayer has been realigning its priorities at the consumer health department as part of a groupwide overhaul Baumann initiated in late 2018. Under the scheme, the German company hived off Dr. Scholl’s foot care line and Coppertone sunscreens. By comparison, it recently bought a majority stake in nutritional supplement startup Care/of, which is putting a digital spin on helping patients select personalized vitamins.