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FDA approves nasal spray for nonprescription use to relieve allergies

This non-steroidal nasal spray is good news for the 60 million people in the U.S. living with allergies

Last week, the FDA announced it has approved Astepro, a  prescription strength, steroid-free antihistamine nasal spray, for over-the-counter use. It’s the first antihistamine nasal spray made available without a prescription. This is good news for those looking to combat their seasonal sniffling symptoms.

What is allergic rhinitis?

There are estimates that more than 60 million people in the U.S. experience symptoms of seasonal allergic rhinitis—aka hay fever, or seasonal allergies. And numbers are increasing year over year. Our 2021 allergy survey found that 59% of respondents have allergies, with the most common being pollen allergies. 

Allergic rhinitis develops when the body’s immune system recognizes and overreacts to something in the environment. It can be either seasonal or perennial, according to the American College of Allergy, Asthma & Immunology (ACAAI). 

Symptoms of seasonal allergic rhinitis can occur in spring, summer, and/or early fall. They are usually caused by allergic sensitivity to airborne mold spores or pollens from trees, grass, and weeds. Conversely, perennial allergic rhinitis—which can be caused by dust mites, pet dander, smoke, etc—causes symptoms year-round.

The symptoms of both perennial and seasonal allergic rhinitis include:

  • Runny nose
  • Itchy eyes, mouth, or skin
  • Sneezing
  • Stuffy nose due to blockage or congestion
  • Fatigue (often reported due to poor quality sleep as a result of nasal obstruction) 

Allergic rhinitis can be treated with over-the-counter products such as Flonase (fluticasone)  or with prescriptions such as Nasonex (mometasone), Astelin (azelastine), or Patanase (olopatadine). The FDA’s over-the-counter approval of Astepro nasal spray means allergy sufferers will have one easier—and cheaper—way to go sneeze-free. It’s the first time a steroid-free, antihistamine nasal spray is available over the counter. Previously, only steroid or decongestant nasal sprays could be purchased without a prescription. 

While those options are effective at reducing inflammation from an allergy reaction, they can have side effects, like rebound congestion (from decongestant nasal sprays), with regular use. Antihistamine sprays help stop your body’s histamine reaction (and your sniffling and sneezing) before it starts.

What is Astepro?

Made by Bayer, Astepro (azelastine) is a nasal spray made with 0.15% of the drug azelastine hydrochloride. This active ingredient is spritzed directly in the nose to relieve nasal symptoms such as runny, itchy, and stuffy nose as well as sneezing caused by allergies. It’s approved for adults and children aged 6 years and older.

How does Astepro work?

Astepro belongs to a class of drugs called antihistamines. Antihistamines are able to block the effects of a substance called histamine in your body.

Histamine is a neurotransmitter that is normally released when your body detects something harmful in your body, like an infection. It signals for the body to swell and react in order to protect itself. But sometimes your body mistakes harmless airborne molecules (such as pollen, pet dander, or smoke) for a threat and signals to your systems to produce histamine. The released histamine causes an allergic reaction with the symptoms listed above.

Antihistamines—whether taken orally or with a nasal spray like Astepro—stop the chain reaction that leads to runny noses and non-stop sneezing. Antihistamines work best if you take them before you come into contact with known allergens, but they can also reduce the severity of symptoms if taken after exposure.

According to Bayer, Astepro is able to provide up to 24 hours of allergy symptom relief for users.

What are the possible side effects of Astepro?

According to Mayo Clinic, some common side effects of Astepro are:

  • Bitter taste in the mouth
  • Drowsiness or sleepiness

Astepro’s label warns that consumers using this product should avoid alcoholic drinks and be careful when driving a motor vehicle or operating machinery. Using azelastine nasal spray with alcohol, sedatives, or tranquilizers may increase drowsiness. Other, less common side effects are possible as well. Consult your healthcare professional for a full list of side effects.

RELATED: Non-drowsy Benadryl: What are your options?

When will Astepro be available?

Currently, Astepro is still only available with a prescription. However, it will soon be available (as Astepro Allergy) for purchase over the counter nationwide in early 2022, according to Bayer. The 0.1% formulation will still be available as Rx-only.