FDA Approves Neffy: Needle-Free Allergy Treatment

The U.S. Food and Drug Administration (FDA) has authorised ARS Pharmaceuticals, Inc. to treat adults and children who weigh ≥30 kg (66 lbs) for Type I Allergic Reactions, including anaphylaxis. For patients and families dealing with severe allergic reactions, this is the first and only needle-free therapy option available. It is also the first major advancement in epinephrine delivery in over 35 years.

Until recently, the only available therapy for people experiencing severe allergic responses, such as anaphylaxis, was an often painful and unsettling needle injection of epinephrine. In many instances, patients might put off or neglect to take the life-saving medication as soon as symptoms appeared, raising the possibility of a serious response or unfavourable results necessitating further emergency care. With the FDA's approval of Neffy, patients with severe allergies now have access to a long-awaited, convenient, needle-free way to administer epinephrine that may shorten the time needed for administration. This could improve patient and carer quality of life as well as clinical outcomes.

There are an estimated 500,000 ER visits due to type I allergic reactions each year, which can end in potentially fatal anaphylaxis and are brought on by foods, drugs, and insect stings. About 60% of these patients said they had not taken an adrenaline shot before going to the emergency room.

Neffy's approval is based on information from five primary registration studies using an intranasal dosage of 2 mg of epinephrine, which satisfied all established clinical goals and showed pharmacokinetic and pharmacodynamic characteristics that were within permissible bounds for injectable products containing epinephrine. No significant nose irritation or discomfort was recorded in any of the clinical studies that included the neffy product, and the majority of adverse events that occurred throughout the clinical trials were moderate.