FDA slaps CRL on Neffy nasal spray NDA

The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Neffy (epinephrine nasal spray) in the treatment of allergic reactions (Type I), including anaphylaxis for adults and children ≥30 kg.

The product’s developer, ARS Pharmaceuticals (Nasdaq: SPRY), whose shares plunge 46% to $3.55 pre-market yesterday, plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of this CRL.

In the letter, the FDA requested 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 (PADAC) in May 2023 to approve Neffy without the need for additional studies to demonstrate its efficacy or safety. Furthermore, the FDA and ARS Pharma previously aligned in August 2023 on final physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling.