Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology

• neffy resulted in robust responses on pharmacodynamic (PD) surrogates of efficacy observed even at 1 minute after dosing, and which were comparable to, or greater in magnitude than, EpiPen
  
• Repeat doses of neffy resulted in statistically greater mean maximum responses on PD surrogates for efficacy compared to EpiPen
  
• Repeat doses of neffy resulted in dose-proportional pharmacokinetic (PK) exposures, unlike injection, which results in less than proportional PK exposure with repeat doses
  

SAN DIEGO, Oct. 03, 2023 (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 the publication of its full pharmacokinetic and pharmacodynamic results from one of its four primary registration studies of neffy (epinephrine nasal spray) in the Journal of Allergy and Clinical Immunology (JACI). JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology. The clinical study evaluated single and repeat doses of neffy compared to single and repeat doses of approved injection products in healthy subjects.

Response on PD surrogates of efficacy

The study showed that neffy elicited comparable or greater response compared to approved injection products (intramuscular (IM) injection with needle and syringe, EpiPen), as measured by pharmacodynamic (PD) profile, the surrogate measure for assessing clinical effectiveness in anaphylaxis. These responses in PD were observed even at 1 minute after a single dose of neffy, with mean maximum changes in heart rate (E_max) statistically greater than both IM injection and EpiPen and mean maximum changes in blood pressure (E_max) statistically greater than IM injection and numerically greater than EpiPen. For repeat doses of neffy, mean maximum changes in PD responses for both blood pressure and heart rate were statistically greater than repeat doses of EpiPen.

“Systolic blood pressure (SBP) and heart rate increases result from activation of adrenergic receptors that reverse the anaphylaxis symptoms. Such PD effects occur almost immediately with neffy, which is highly reassuring from a clinical perspective,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in Allergy/Immunology at the University of South Florida in Tampa, and lead author of the study. “Repeat dosing of neffy results in even greater and sustained increases in PD response compared to EpiPen, which could be clinically important in severe cases of anaphylaxis that often need a repeat dose of epinephrine, where patients may experience hypotensive crisis.”