Full Press Release Details
SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced the Opposition Division of the European Patent Office (the “EPO”) upheld the validity of all claims in EP 3678649, which is a patent validated in over 30 European countries directed to nasal spray epinephrine formulations including alkyl-glycoside, such as Intravail®, and uses thereof.
ARS Pharma’s issued global intellectual property portfolio related toneffyprovides coverage until at least 2039.
Earlier this year, following successful defense of an Inter Partes Review (IPR) challenge and subsequent appeal proceedings, the United States Patent and Trademark Office formally upheld key claims for U.S. Patent No. 10,682,414, which is directed to methods of treating a type-1 hypersensitivity reaction, including anaphylaxis, using an epinephrine aqueous nasal spray.
Thus, two different ARS Pharma patents, with differing claim scope, have now been successfully upheld following two independent patent challenges in two different jurisdictions.
“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,” said Richard Lowenthal Co-Founder, President and CEO of ARS Pharma. “These positive outcomes with our EP patent on top of the earlier IPR and Appeals court decisions on one of our U.S. methods of use patents, provide confidence in our ability to overcome future patent challenges to our worldwide patent estate that covers intranasal epinephrine.”
Aboutneffy®neffyis a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
INDICATION AND IMPORTANT SAFETY INFORMATION FORneffy(epinephrine nasal spray)
INDICATIONneffyis indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.
IMPORTANT SAFETY INFORMATIONneffycontains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.
Always carry twoneffynasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose ofneffyif symptoms continue or come back.Eachneffycontains a single dose of epinephrine.neffyis for use in the nose only.
Useneffyright away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose ofneffy, a second dose is needed. If needed, administer a second dose using a newneffyin the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after usingneffy.
Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.
Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies.neffyand other medications may affect each other, causing side effects.neffymay affect the way other medicines work, and other medicines may affect howneffyworks.
neffymay cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you useneffy.
Common side effects ofneffyinclude: 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.
Tell your healthcare provider if you have any side effects that bother you or that do not go away after usingneffy.
These are not all of the possible side effects ofneffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
Please see the fullPrescribing InformationandPatient Informationforneffy.
About Type I Allergic Reactions Including AnaphylaxisType I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializingneffy®(trade nameEURneffy®in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated 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, and in the EU for emergency treatment of allergic reactions (anaphylaxis) 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. For more information, visitwww.ars-pharma.com.
Forward-Looking StatementsStatements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: beliefs about ARS Pharma’s patent portfolio; ARS Pharma’s belief in its ability to protect its patent portfolio; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expects,” “if,” “intend,” “may,” “potential,” “plans,” “suggest,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications fromneffy; the ability to maintain regulatory approval forneffyin its currently approved indications the scope, progress and expansion of developing and commercializingneffy; the potential for governments and payors to delay, limit or deny coverage forneffy; the size and growth of the market forneffyand the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies.
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 13, 2025. These documents can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visitwww.ars-pharma.com, and follow us onLinkedInandX.