On Friday, the FDA approved ARS Pharmaceuticals Inc’s neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), for adult and pediatric patients.

ARS Pharma’s Neffy is to be an alternative to EpiPen and other autoinjectors like Sanofi SA’s  Auvi-Q filled with epinephrine.

The approval comes almost two months before the PDUFA target action of October 2, 2024.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” said Kelly Stone, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research.

Neffy’s approval is based on four studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following the administration of Neffy or approved epinephrine injection products.

Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.

Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in treating anaphylaxis.

A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy. 

Neffy is a single-dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if symptoms do not improve or worsen.

In February, ARS Pharmaceuticals ( SPRY ) released topline results from its clinical study comparing repeat doses of neffy to repeat doses of epinephrine intramuscular injection that was submitted as part of its response to the complete response letter (CRL).

In September 2023, the FDA rejected ARS Pharma’s Neffy application and requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of Neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.

Price Action: SPRY stock is up 12.01% at $11.08 at the last check on Friday.

Read Next:

Lung Disease Focused AN2 Therapeutics’ Lackluster Data Prompts To Stop Phase 3 Study Of Lung Infection Candidate, Halves Workforce.