ARS Pharmaceuticals Announces FDA Acceptance of NDA for neffy® (Epinephrine Nasal Spray) for the Treatment of Allergic (Type I) Reactions, Including Anaphylaxis
SAN DIEGO–(BUSINESS WIRE)–ARS Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ARS’ New Drug Application (NDA) for neffy for the emergency treatment of allergic reactions (Type I), including anaphylaxis in adults and children ≥ 30 kg (66 lbs). If FDA approved, neffy would be the first non-injectable treatment available for patients with allergic (Type I) reactions, including anaphylaxis.
The FDA has assigned a Target Action Date for the Prescription Drug User Fee Act (PDUFA) which is expected in mid-2023.
“The FDA’s acceptance of our NDA for neffy is a major step in our efforts to bring patients the ability to deliver epinephrine with pharmacokinetics comparable to an intramuscular injection, but in a needle-free, easy-to-deliver nasal spray,” said Richard Lowenthal, President and CEO from the management of ARS Pharmaceuticals. “We appreciate the FDA’s recognition of the potential clinical benefit of this new approach to treating patients with severe allergies and we look forward to working with the FDA during this process, with the goal of potentially changing the treatment paradigm for millions of patients with or at risk of severe allergic reactions (type I).
The NDA’s submission to the FDA was based on data from four primary registration studies supporting that an intranasal dose of 2 mg of neffy met all clinical parameters recommended by regulatory agencies and that its pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and administration by a caregiver, as well as in children with Type I allergies ≥ 30 kg (66 lb). In addition, neffy has been well tolerated to date with over 500 people receiving at least one dose, and many with repeated administration. The majority of adverse events in clinical trials were mild in nature, with no significant nasal irritation or pain.
About Allergic (Type I) Reactions, Including Anaphylaxis
Severe Type I allergic reactions are serious and life-threatening events that can occur minutes after exposure to an allergen and require immediate treatment with epinephrine, the only drug approved by the FDA for these reactions. Although epinephrine auto-injectors have been shown to be very effective, there are well-published limitations that cause many patients and caregivers to delay or not administer treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle safety issues, unreliability, and device complexity. There are approximately 25 to 40 million people in the United States who experience severe Type I allergic reactions. Of these, only 3.3 million currently have an active prescription for epinephrine auto-injector, and among of these, only half systematically carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half delay or do not administer the device in an emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves against severe allergic reactions that can lead to anaphylaxis. The business is growing neffy® (formerly known as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions, including foods, drugs, and insect bites that can lead to life-threatening anaphylaxis . For more information, visit www.ars-pharma.com.