EURneffy Nasal Spray Approved in EU as First Needle-Free Anaphylaxis Treatment

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company focused on developing treatments for severe allergic reactions, has announced that the European Commission has approved EURneffy® (adrenaline nasal spray) for emergency treatment of allergic reactions, including anaphylaxis. This decision on August 22, 2024, follows the U.S. FDA's approval on August 9, 2024. EURneffy now offers a novel, needle-free adrenaline delivery method for adults and children (≥30 kg) in Europe, the first of its kind in over 30 years.

Adrenaline remains the primary treatment for severe allergic reactions. However, its use has been limited due to the drawbacks of current injectable treatments. Professor Antonella Muraro from the University of Padua, a leading expert on anaphylaxis treatment guidelines, highlighted the underutilization of adrenaline due to the challenges posed by existing injectable options. The approval of EURneffy addresses these issues by providing a needle-free alternative, which may encourage more consistent use among patients who might otherwise hesitate.

Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, emphasized the significance of this approval for the severe allergy community in the EU. He noted that EURneffy's needle-free form, combined with its smaller size and longer shelf-life, could enhance the likelihood that patients would carry and use the treatment when necessary, thereby improving outcomes for allergic reactions.

The European Commission's approval was based on extensive data from one of the largest nasal spray development programs ever conducted. This program included over 700 participants and more than 1,200 administrations. The studies evaluated the pharmacodynamics and pharmacokinetics of the 2 mg dose of EURneffy across various conditions, such as single and repeat dosing, self-administration, pediatric use, and during nasal conditions like congestion and rhinorrhea caused by allergies or infections.

EURneffy benefits from substantial data protection, including an eight-year period during which other applicants cannot use its data and a ten-year marketing protection period preventing generic, hybrid, or biosimilar versions from entering the EU market. The issued patents covering EURneffy in Europe are valid until 2039.

ARS Pharma plans to make EURneffy available in certain EU Member States by Q4 2024 through a pharmaceutical partner with an established presence in Europe. EURneffy is marketed under the name neffy® (epinephrine nasal spray) in the European Union.

Type I severe allergic reactions, including anaphylaxis, are serious and potentially life-threatening events requiring immediate treatment with epinephrine. Despite the effectiveness of adrenaline autoinjectors, many patients and caregivers delay or refrain from using them due to needle fears, portability issues, safety concerns, reliability doubts, and device complexity. More than half of the patients who carry an autoinjector fail to use it promptly during emergencies.

ARS Pharmaceuticals is dedicated to improving patient protection against severe allergic reactions. The company is commercializing neffy® (EURneffy in the EU), an intranasal epinephrine product for treating Type I allergic reactions, including those caused by food, medications, and insect bites, which can lead to life-threatening anaphylaxis.