ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine.
The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription Drug User Fee Act).
ARS Pharmaceutical developed neffy with the Neurelis Intravail transmucosal absorption enhancement technology. Intravail enhances drug absorption through the nasal mucosa. This enables the noninvasive delivery of protein, peptide and small-molecule drugs.
“The FDA’s acceptance of the neffy NDA marks a major milestone in the development of a non-injectable anaphylactic rescue medication. The potential quality of life implications for millions of people with severe type I allergic reactions is profound,” said Neurelis CEO Craig Chambliss. “If approved, neffy will be the latest FDA-approved product utilizing Intravail, following the recent successful introduction of VALTOCO (diazepam nasal spray) to the epilepsy community.”
According to Neurelis, it could potentially become the first non-injectable treatment for patients with severe type I allergic reactions. Those severe reactions include anaphylaxis. It features convenience, ease-of-use and rapid administration, the company said.
Compared to available epinephrine treatment options, it is simple to use and needle-free. The nasal administration offering features a low-dose, aqueous formulation of epinephrine.
The company based its NDA submission for neffy on data from four primary registration studies. Those studies demonstrated that a 2mg intranasal dose of neffy met all clinical endpoints recommended by regulators. Its pharmacokinetics fell within the range of approved epinephrine injection products, too.