ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed earlier this year. According to ARS Pharma, the letter also requested additional nitrosamine testing, which found no measurable levels of nitrosamines. The company says that it now expects the FDA to set a PDUFA date of October 2, 2024 for completion of its review of the NDA.
The FDA accepted ARS Pharma’s NDA for Neffy in October 2022, and the agency’s Pulmonary-Allergy Drug Advisory Committee (PADAC) voted to support approval of the NDA in May 2023. The FDA announced in June 2023 that it would delay completion of its review of the Neffy NDA until September 19.
ARS Pharma President and CEO Richard Lowenthal commented, “After approximately 6 months of receiving the CRL for Neffy, we were able to pivot quickly to successfully complete the repeat dosing nasal allergen challenge study and updated nitrosamine testing with no measurable levels of nitrosamines detected, and submit our response to the CRL. Based on multiple meetings with the FDA, we believe that we have responded fully and completely to the agency’s concerns and appreciate its insights along the way. Our focus on addressing any requests from the FDA to optimize our labeling remains critical in our mission to bring Neffy to patients, providers, and caregivers who continue to show substantial enthusiasm for a needle-free, safe, effective, and easy-to-carry epinephrine solution. We look forward to working with the FDA in our efforts to make Neffy available to allergy patients as soon as possible.”
Read the ARS Pharmaceuticals press release.
