If approved by the regulatory agency, neffy would be the first non-injectable treatment available to patients suffering with allergic reactions of Type I, including anaphylaxis.
The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is expected in mid-2023.
ARS Pharma president and CEO Richard Lowenthal said: “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.
“We appreciate that the FDA recognises 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 submission of NDA to the regulatory body was based on data from four primary registration studies supporting that a 2mg intranasal dose of neffy achieved all clinical endpoints suggested 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, besides children with Type I allergies ≥30 kg (66 lbs).
Furthermore, neffy has been found to be tolerated well to date with over 500 individuals receiving at least one dose, and several with repeat administration.
Most of adverse events in clinical trials were of mild nature without leading to any meaningful nasal irritation or pain.
On 21 July 2022, ARS Pharma entered into a definitive agreement to merge with Silverback in an all-stock transaction.
The deal is subject to customary closing conditions, including the approval by Silverback’s stockholders.
The merger is expected to complete in Q4 2022.