US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine product, neffy (epinephrine nasal spray) 2 mg, have been submitted by its licensing partners in China, Japan, and Australia.
Neffy’s Role in Treating Type I Allergic Reactions
Neffy is indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis, which can be triggered by food, medications, and insect bites. The product is designed for patients who may experience life-threatening anaphylaxis and is approved in the United States for adult and pediatric patients weighing 30 kg or more.
Clinical Studies Supporting International Market Expansion
Multiple clinical studies have been conducted to support the market filings in Japan and China. These studies found that 100% of patients who received neffy for symptomatic anaphylaxis responded to a single dose, with a median time to complete resolution of symptoms at 16 minutes. Additionally, pharmacokinetic/pharmacodynamic (PK/PD) studies conducted in China demonstrated high similarity to the results from US clinical trials with neffy.
Partnerships and Global Rights for Neffy
ARS Pharmaceuticals has established partnerships for the distribution of neffy, with Pediatrix Therapeutics in China, Alfresa Pharma in Japan, and CSL Seqirus in Australia and New Zealand. The company retains all rights for neffy in the US market, while commercialization rights in Europe, Canada, and other regions outside the US are held by ALK-Abelló.-Fineline Info & Tech
