FDA Approves First Nasal Spray for Severe Allergies

The U.S. Food and Drug Administration (FDA) has granted approval for Neffy, a nasal spray developed by ARS Pharmaceuticals, designed to treat allergic reactions, including severe anaphylaxis, in individuals weighing at least 66 pounds. This decision follows a previous rejection nearly a year ago, when the FDA requested additional trial data to assess the safety of repeated doses of the spray. Neffy contains epinephrine, the same active ingredient found in EpiPens, but offers a non-injection delivery method through the nasal route. Dr. Céline Gounder, a medical contributor for CBS News, highlighted the significance of this alternative, particularly for parents who may be apprehensive about using needles. She noted that Neffy appears to be as effective as EpiPens, providing a reassuring option for families managing severe allergies. Despite its benefits, Gounder emphasized that Neffy is not a substitute for emergency medical care. After using the spray, patients are advised to seek immediate attention at an emergency room, as further treatment may be necessary. The nasal spray is intended to serve as a rescue medication rather than a definitive solution for allergic reactions. Potential side effects of Neffy include nasal and throat irritation, headaches, and jitteriness. ARS Pharmaceuticals anticipates that the drug will be available to consumers approximately eight weeks following the FDA's approval.