December 9, 2022

FDA approves over-the-counter antihistamine nasal spray


The United States Food and Drug Administration (FDA) has approved a formulation of azelastine (Astepro) nasal spray for the non-prescription treatment of allergies, making it the first over-the-counter nasal antihistamine in the United States.

Azelastine hydrochloride 0.15% nasal spray now approved for over-the-counter treatment of seasonal and perennial illnesses allergic rhinitis in adults and children 6 years or older, the agency said. The 0.1% strength remains a prescription product indicated for young children.

“Today’s approval gives individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” said Theresa M. Michele, MD, director of the Bureau of Drugs. over-the-counter to the FDA’s Center for Drug Evaluation and Research, in a prepared statement.

The FDA has granted non-prescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray will be available in national retail stores starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritine), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for allergy relief inside and out in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine might be a better option for some people with allergies than what’s already over the counter, said Tracy Prematta, MD, an allergist in private practice at Delaware Valley Allergy in Havertown, Pennsylvania.

“In general, I like nasal antihistamines,” Prematta said in an interview with Medscape Medical News. “They work quickly, unlike nasal steroids, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something fast-acting.”

However, the cost of over-the-counter azelastine may play a significant role in choosing patients with the prescription or non-prescription option, according to Prematta.

Bayer has yet to set the price for over-the-counter azelastine, a company spokesperson told Medscape.

The change in approval status of azelastine occurred through a regulatory process called Rx switch to OTC. According to the FDA, products transitioned to non-prescription status must have data demonstrating that they are safe and effective in self-medication when used as directed.

The manufacturer of the product must show that consumers know how to use the drug safely and effectively without a medical professional supervising them, the FDA said.

The FDA views the change in azelastine status as a partial change from Rx to OTC, as the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years of age and seasonal allergies for children 2 to 6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to the prescribing information, consumers using the nasal spray should be careful while driving or using machines and should avoid alcohol.

Using the product with alcohol, sedatives or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with oral antihistamines that people take to treat their allergies, said Prematta, who added that patients may also complain of dry mouth, nose or throat.

Although some people with allergies do not like the taste of antihistamine nasal spray, they can try to overcome this problem by tilting their head forward, pointing the tip of the mouthpiece to the outside of the nose, and sniffing gently. , Prematta said.

“It really minimizes what goes through the back of your throat so the taste becomes less of a problem,” she explained.

Prematta did not disclose any relevant financial relationship.

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