Many consumers are familiar with EpiPens and other epinephrine injectables when treating severe allergic reactions.
Now, the Food and Drug Administration (FDA) has approved the first non-injectable treatment for anaphylaxis, a nasal spray dubbed “neffy.”
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research.
“Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”
What to know about neffy
When a patient is experiencing anaphylaxis, neffy works much in the same way as traditional injectable treatments. Pediatric and adult patients who weigh at least 66 pounds receive one spray into one nostril. If symptoms don’t improve or remain the same, they can receive a second spray into the same nostril.
Some of the most common side effects of neffy include:
Nasal discomfort
Tingling sensation
Sneezing
Nasal congestion
Throat irritation
Feeling jittery
Itchiness inside the nose
Numbness in the mouth
Fatigue
Gum pain
Dizziness
Abdominal pain
Nausea and vomiting
Sneezing
People with a history of allergic reactions to sulfite, as well as those with a history of nasal polyps or nasal surgery, are encouraged to consider alternative options for anaphylactic treatment.
Clinical trials prove neffy’s success
Prior to the FDA’s approval of neffy, manufacturers conducted four clinical trials to test the efficacy of the drug.
The researchers compared the levels of epinephrine in blood samples of 175 adults when administering neffy and traditional injectable epinephrine. The adults involved in the study had no history of anaphylaxis.
Ultimately, neffy proved to hold up against traditional injectable treatments in key areas: blood pressure, heart rate, and epinephrine blood concentrations.
Neffy is expected to be available in the U.S. within eight weeks of the official approval, and ARS Pharmaceuticals has been approved as the drug’s manufacturer.