China-based Pediatrix Therapeutics has announced that the New Drug Application (NDA) for its neffy (epinephrine nasal spray) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication for neffy is the emergency treatment of type I allergic reactions, including severe allergic reactions, in adults and children weighing 30 kg or more.
Neffy: A Novel Intranasal Epinephrine Product
Neffy is an intranasal epinephrine product developed by ARS Pharmaceuticals, Inc. (NASDAQ: SPRY). In January 2021, ARS Pharmaceuticals granted Pediatrix the development and commercialization rights to the drug in Greater China through a licensing agreement. Neffy (epinephrine nasal spray) 2 mg received approval in the US and European Union in August 2024, making it the first non-injectable treatment product for type I allergic reactions, including severe allergic reactions.
Regulatory Progress and Future Potential
In addition to the 2 mg formulation, the 1 mg dosage form of neffy is currently awaiting regulatory decisions in the US for the emergency treatment of type I severe allergic reactions in patients weighing between 15 kg and 30 kg. The acceptance of the NDA by the NMPA marks a significant step forward for Pediatrix Therapeutics in expanding access to this innovative treatment for allergy sufferers in China.-Fineline Info & Tech
