ALK-Abello Pharmaceuticals announced that Health Canada has approved neffy® 2 mg for the 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 adult and pediatric patients who weigh 30 kg or greater.
This approval addresses a critical need for Canadians affected by severe allergies that put them at risk of anaphylaxis. It is estimated that up to 2.5 million people in Canada are affected by severe allergies. Research shows that half of those living with a life-threatening allergy do not consistently carry their prescribed epinephrine auto-injector and approximately half do not administer an auto-injector device when needed in an emergency.
Dr. Anne Ellis, allergist and chair of the division of allergy and immunology at Queen's University said, "The gap between those who have severe allergies and are at risk for anaphylaxis, and those who actually carry self-administered epinephrine is a serious issue. Anaphylaxis can occur within minutes of exposure to allergens and rapid treatment with epinephrine is critical to treatment success. However, many patients and caregivers don't carry their epinephrine autoinjector or hesitate to use it, often due to needle fear and uncertainty about correct administration. A needle-free nasal spray that people can use confidently and easily may help improve how quickly and effectively people respond to an anaphylactic reaction."
neffy® is designed to fit into a pocket for portability. It also has a 30-month shelf life from time of manufacture and can withstand temperature excursions up to 50°C, key differentiators from autoinjectors.
neffy® 2 mg was approved in Canada following clinical studies involving more than 700 participants. No serious side effects were reported.1 The most frequently occurring adverse reactions (very common events ≥ 10%) observed in clinical studies of neffy® were reported only after a second 2 mg dose (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%).
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