Regulatory Setback For EpiPen Alternative - FDA Issues CRL To ARS Pharmaceuticals' Allergic Reaction Nasal Spray

The FDA issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's SPRY New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis (fatal allergic reaction) for adults and children ≥30 kg. 

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

In the letter, the FDA 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. 

This request comes after the recommendation of the FDA Advisory Committee in May 2023 to approve neffy without needing additional studies to demonstrate its efficacy or safety. 

ARS Pharma anticipates a resubmission to the FDA in the first half of 2024, positioning ARS Pharma for an anticipated FDA action date in the second half of 2024.

ARS Pharma expects to have anticipated cash, cash equivalents, and short-term investments of approximately $195 million at the time of the anticipated launch of neffy if approved in 2H of 2024.

The CRL requested additional information on nitrosamine impurities to be tested for based on new draft guidance issued after the neffy NDA submission.

ARS Pharma does not believe the additional testing would be a rate-limiting step for its resubmission to the FDA.

A marketing authorization application for neffy is also under review by the European Medicines Agency, with a Committee for Medicinal Products for Human Use opinion expected by the end of 2023.

Price Action: SPRY shares are down 58.5% at $2.74 during the premarket session on the last check Wednesday.