ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1.
The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites.
ARS Pharmaceuticals reported that the ARS-1 aqueous intranasal formulation was developed with a novel nasal absorption technology called Intravail. In clinical studies, ARS-1 had comparable pharmacokinetics to an intramuscular injection of epinephrine, the company added.
A needle-free epinephrine product could help encourage people to deliver epinephrine in emergency situations with less hesitation as compared to traditional epinephrine auto-injectors, ARS Pharmaceuticals touted.
“The FDA’s decision to grant fast track designation for our novel intranasal epinephrine spray is an important milestone in our mission to deliver a reliable needle-free treatment option that is easier to carry and use for the emergency treatment of severe allergic reactions that could lead to anaphylaxis,” president & CEO Richard Lowenthal said in prepared remarks.
“Fast track designation is an acknowledgement from the FDA of the potential contribution of our low dose intranasal epinephrine product for patients and caregivers, and we look forward to advancing the development of ARS-1 so it is available to the community as soon as possible,” Lowenthal added.