ARS Pharmaceuticals has taken a step toward FDA approval of its epinephrine nasal spray. Seeking to challenge EpiPen, the San Diego-based company has had its application for approval accepted and put itself on track to learn its fate around the middle of next year.
The candidate, branded Neffy, is designed to provide injection-like absorption of epinephrine at a low dose from a small, rapidly administered and reliable nasal spray. ARS is pitching the product as a solution to issues that it argues can delay or prevent the use of Viatris’ injectable allergic reaction incumbent EpiPen, such as fear of needles, a lack of portability and the complexity of the device.
ARS is now set to learn what the FDA makes of the candidate. The agency has accepted a submission for approval of Neffy for review and assigned a mid-2023 PDUFA decision date to the process.
The new drug application is built on data from four clinical trials that evaluated the effects of delivering a 2mg dose of epinephrine via the Neffy nasal spray. The studies assessed the administration of the drug by patients and caregivers in adults and tested the treatment in children weighing 30kg or more.
If approved, Neffy could become the first non-injectable medicine indicated to treat allergic reactions including anaphylaxis in the U.S. ARS has predicted that 60% of epinephrine pen users would switch to Neffy immediately upon approval of the nasal spray.
To fund the approval and commercialization of Neffy, ARS recently struck a reverse merger with Silverback Therapeutics. The deal will secure ARS a Nasdaq listing and the $240 million in cash that it expects Silverback to have when the merger closes.