ARS Pharmaceuticals announces results from repeat dosing study of neffy

ARS Pharmaceuticals announced topline results from its clinical study comparing repeat doses of neffy to repeat doses of epinephrine intramuscular injection, as requested by the FDA with and without nasal allergen challenge 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.”