ARS Pharmaceuticals announced that the Opposition Division of the European Patent Office (EPO) has upheld the validity of all claims in EP 3678649, a patent validated in over 30 European countries covering nasal spray epinephrine formulations including alkyl-glycoside components such as Intravail®. The decision strengthens the company's intellectual property position for neffy®, its epinephrine nasal spray for emergency treatment of anaphylaxis.
The favorable EPO ruling follows ARS Pharmaceuticals' successful defense of patent challenges in the United States earlier this year. The U.S. Patent and Trademark Office formally upheld key claims for U.S. Patent No. 10,682,414, which covers methods of treating type-1 hypersensitivity reactions, including anaphylaxis, using epinephrine aqueous nasal spray. These victories represent successful defense of two different patents with differing claim scope across two independent jurisdictions.
Patent Portfolio Provides Extended Market Protection
ARS Pharmaceuticals' global intellectual property portfolio related to neffy now provides coverage until at least 2039. Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma, stated that "the decisive and unanimous opinion of the EPO committee in rejecting all of the opposition arguments and upholding the novel claims in our European patent supports the strength and validity of our extensive patent portfolio."
The company's patent protection extends across multiple jurisdictions, with neffy approved in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater. In the European Union, where it is marketed as EURneffy®, the product is indicated for emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced anaphylaxis in adults and children who weigh 30 kg or greater.
Addressing Critical Treatment Gaps in Anaphylaxis Care
The patent protection comes as neffy addresses significant unmet needs in anaphylaxis treatment. According to ARS Pharmaceuticals, approximately 40 million people in the United States experience Type I allergic reactions. Of the approximately 20 million people diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis over the last three years, only 3.2 million filled their active epinephrine auto-injector prescription in 2023. Among those who did fill prescriptions, only half consistently carry their prescribed auto-injector.
Even when patients or caregivers have access to auto-injectors, more than half either delay or do not administer the device when needed in an emergency. The limitations of current epinephrine auto-injectors include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and device complexity.
Clinical Profile and Safety Considerations
Neffy contains epinephrine and is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater. The nasal spray formulation is designed for intranasal use only, with each device containing a single dose of epinephrine.
The recommended dosing protocol involves immediate administration upon recognition of allergic reaction symptoms. If symptoms continue or worsen after the first dose, a second dose should be administered using a new neffy device in the same nostril, starting 5 minutes after the first dose. Patients are advised to always carry two neffy nasal sprays due to the unpredictable nature of anaphylactic reactions and the potential need for a second dose.
Common side effects of neffy include nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation including in the nose, feeling tired, dizziness, nausea, and vomiting. The product carries important safety considerations for patients with underlying structural or anatomical nasal conditions and various medical conditions including heart problems, kidney problems, Parkinson's disease, thyroid problems, high blood pressure, and diabetes.
