ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy (Epinephrine Nasal Spray)

• Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance
• Submission of CRL response triggers up to six-month review period by the FDA

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that it has submitted its response to the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for neffy (epinephrine nasal spray), for the treatment of Type I allergic reactions including anaphylaxis.

The submission follows receipt of a Complete Response Letter (CRL) from the FDA in September 2023, which identified two additional requests: completion of a repeat dose pharmacokinetic (PK) / pharmacodynamic (PD) study of neffy under nasal allergen challenge (NAC) conditions, and completion of updated nitrosamine testing per the FDA’s draft guidance issued in August 2023.

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions. ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.

“After approximately six 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,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “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.”