Silverback Therapeutics Announced FDA's Acceptance of ARS Pharmaceuticals' NDA for Neffy (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) Including Anaphylaxis

Author: Charles Gross | October 21, 2022 07:32am
Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ARS Pharmaceuticals, Inc.'s (ARS Pharma) 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 approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023. "The FDA acceptance of our NDA for neffy is a major milestone in our efforts to bring to patients the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in a needle-free and simple to administer nasal spray," said Richard Lowenthal, President and CEO of ARS Pharma. "We appreciate that the FDA recognizes the potential clinical benefit of this novel approach to treating patients with severe allergies and look forward to working with the FDA during this process, with the goal of potentially changing the treatment paradigm for the millions of patients with or at-risk for severe allergic reactions (type I)." The NDA submission to the FDA was based on data from four primary registration studies supporting that a 2 mg intranasal dose of neffy met all clinical endpoints recommended by regulators and that its pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 500 individuals receiving at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature without any meaningful nasal irritation or pain.

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