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
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.
- “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
- With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
- The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
- In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.