공시 • Apr 17
ARS Pharmaceuticals, Inc. Announces Approval of Neffy Epinephrine Nasal Spray in Canada
ARS Pharmaceuticals, Inc. announced that Health Canada has granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more. neffy offers a new delivery method for epinephrine in Canada for adults and children (>30 kg) living with severe allergic reactions. ALK- Abelló A/S, which licenses the rights to market neffy in Canada, expects availability in the summer of 2026. neffy’s needle-free design reduces barriers to timely treatment while fitting more naturally into everyday life. It is easy to carry, simple to use, has a 30-month shelf life, temperature excursions up to 122oF (50oC), and, if accidentally frozen, can be used once thawed. ARS Pharma entered into an exclusive licensing agreement with ALK- Abelló A/S (ALK) in November 2024, providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S. Under the terms of the agreement, ARS Pharma has received upfront and milestone payments of $155 million to date and is eligible to receive up to an additional $310 million in regulatory and sales milestones, as well as tiered, double-digit royalties in the teens on net sales in licensed geographies. ARS Pharma will be responsible for manufacturing and supplying neffy to ALK in Canada and expects neffy to be available in the summer of 2026. ARS Pharma anticipates filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg with Health Canada by this summer. The regulatory clearance in Canada follows the latest granted approval in China for neffy in partnership with Pediatrix Therapeutics. The National Medical Products Administration (NMPA) in China is responsible for evaluating medicines and medical devices, previously granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh 30 kg or more in December 2025. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months. neffy is commercially available in the U.S. for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children who weigh at least 33 pounds (15 kg). neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater. neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater. neffy contains 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 two neffy nasal sprays with because may not know when anaphylaxis may happen and because may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as it is noticed symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in 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 using neffy. Tell the healthcare provider if there is underlying structural or anatomical nasal conditions, about all the medicines take, and about all medical conditions, especially if there is the heart problems, kidney problems, low potassium in the blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell the healthcare provider if take or use other nasal sprays or water pills (diuretics) or if take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. neffy may cause serious side effects. If there is certain medical conditions or take certain medicines, the condition may get worse, or may have more or longer lasting side effects when there is a use of neffy. 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. Tell the healthcare provider if there is any side effects that bother or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call the healthcare provider for medical advice about side effects.