ARS Pharmaceuticals presented data this weekend at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting supporting neffy, a needle-free emergency epinephrine device that administers the drug via nasal spray.
The company presented clinical data from a rigorous registration program for neffy 2.0 mg of more than 600 subjects, including analyses of patients with upper respiratory tract infections, pediatric patients ≥30kg with a history of type I allergic reaction, patients with allergen-induced allergic rhinitis and the relationship between body weight/BMI and epinephrine exposure.
The data demonstrates the pharmacokinetics of neffy are independent of BMI or body weight. Unlike injection products where exposures decreased with varying BMI or body weight, neffy could be a potentially effective epinephrine product in these patients.
In separate presentations, ARS presented data showing:
- Acute allergic rhinitis (including stuffy nose) induces increases in circulating epinephrine and heart rate;
- The pharmacokinetic profile of neffy 2.0 mg in pediatric allergy subjects is comparable to what has been observed in adults and is expected to be a safe and effective option for the treatment of type I allergic reactions (including anaphylaxis) in pediatric subjects;
- Based on data collected during neffy’s the rigorous registration program, the company showed that intramuscular and subcutaneous injections have a negative relationship with epinephrine exposures while neffy does not, suggesting neffy could be a more effective epinephrine alternative to injection products in patients with elevated body weight or BMI;
- Epinephrine absorption via neffy 2.0 mg under viral upper respiratory tract infection did not significantly impact the pharmacokinetics and pharmacodynamics. neffy 2.0 mg is expected to be a safe and effective option for the treatment of type I allergic reactions (including anaphylaxis) in patients experiencing upper respiratory tract infections.
Said Dr Sarina Tanimoto, MD, PhD, Chief Medical Officer and Co-Founder of ARS Pharma:
At ARS Pharma, we are committed to advancing much-needed science in allergic diseases to make a positive impact on the people and communities we serve. To that end, we are pleased to share these clinical data that provide critical insights into neffy’s potential as the first intranasal medicine for treating severe allergic reactions. Severe allergic reactions can be life-threatening, and today’s standard of care is needle-bearing injectable devices associated with numerous administration challenges. The data generated supports that neffy achieves a PK/PD profile comparable to injectable products across various patient subgroups while potentially allowing patients to easily carry and confidently administer epinephrine without hesitation or anxiety.