ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Repeat doses of neffy under nasal allergen challenge demonstrate a pharmacokinetic profile greater than or similar to injection, and a pharmacodynamic profile greater than injection

Company believes completion of repeat dosing study and nitrosamine assessments address the deficiencies identified in the U.S. Food and Drug Administration (FDA)’s Complete Response Letter (CRL)

NDA on track to respond to CRL early in the second quarter of 2024 followed by an expected six-month review period

SAN DIEGO, Feb. 20, 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, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

“We are very pleased with the topline results from our repeat dose study of neffy under nasal allergen challenge conditions, which we believe will address FDA’s requests in their Complete Response Letter and support the approval of neffy for the treatment of Type I allergies, including anaphylaxis,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge. The results show that the neffy pharmacokinetic and pharmacodynamic profile is greater than or similar to intramuscular injection, the comparator FDA requested for this study. In particular, repeat dosing in the same nostril was greater in exposure than dosing once in each nostril and greater than injection on both PK exposures and PD response at all time points, which may help inform labeling and instructions for use. With these results, we are completing the necessary work to submit our response to FDA in the next couple of months. We look forward to working with the Agency in our efforts to make neffy available to patients as soon as possible.”