ARS Prescribed drugs introduced knowledge this weekend on the 2023 American Faculty of Allergy, Bronchial asthma and Immunology Annual Scientific Assembly supporting neffy, a needle-free emergency epinephrine machine that administers the drug by way of nasal spray.
The corporate introduced scientific knowledge from a rigorous registration program for neffy 2.0 mg of greater than 600 topics, together with analyses of sufferers with higher respiratory tract infections, pediatric sufferers ≥30kg with a historical past of kind I allergic response, sufferers with allergen-induced allergic rhinitis and the connection between physique weight/BMI and epinephrine publicity.
The info demonstrates the pharmacokinetics of neffy are impartial of BMI or physique weight. Not like injection merchandise the place exposures decreased with various BMI or physique weight, neffy may very well be a doubtlessly efficient epinephrine product in these sufferers.
In separate displays, ARS introduced knowledge displaying:
- Acute allergic rhinitis (together with stuffy nostril) induces will increase in circulating epinephrine and coronary heart price;
- The pharmacokinetic profile of neffy 2.0 mg in pediatric allergy topics is akin to what has been noticed in adults and is predicted to be a secure and efficient choice for the therapy of kind I allergic reactions (together with anaphylaxis) in pediatric topics;
- Based mostly on knowledge collected throughout neffy’s the rigorous registration program, the corporate confirmed that intramuscular and subcutaneous injections have a unfavorable relationship with epinephrine exposures whereas neffy doesn’t, suggesting neffy may very well be a simpler epinephrine various to injection merchandise in sufferers with elevated physique weight or BMI;
- Epinephrine absorption by way of neffy 2.0 mg underneath viral higher respiratory tract an infection didn’t considerably influence the pharmacokinetics and pharmacodynamics. neffy 2.0 mg is predicted to be a secure and efficient choice for the therapy of kind I allergic reactions (together with anaphylaxis) in sufferers experiencing higher respiratory tract infections.
Stated Dr Sarina Tanimoto, MD, PhD, Chief Medical Officer and Co-Founding father of ARS Pharma:
At ARS Pharma, we’re dedicated to advancing much-needed science in allergic ailments to make a optimistic influence on the individuals and communities we serve. To that finish, we’re happy to share these scientific knowledge that present important insights into neffy’s potential as the primary intranasal medication for treating extreme allergic reactions. Extreme allergic reactions could be life-threatening, and as we speak’s commonplace of care is needle-bearing injectable gadgets related to quite a few administration challenges. The info generated helps that neffy achieves a PK/PD profile akin to injectable merchandise throughout varied affected person subgroups whereas doubtlessly permitting sufferers to simply carry and confidently administer epinephrine with out hesitation or nervousness.