FDA Issues Complete Response Letter for neffy (epinephrine nasal spray) New Drug Application with Request for Additional Study

Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions

FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and without recommending additional trials

FDA now requests repeat-dose study be completed prior to neffy approval as opposed to previously agreed-upon post-marketing requirement

Well-capitalized with anticipated cash, cash equivalents and short-term investments on hand of approximately $195 million at the time of our anticipated neffy launch, if approved in 2H24, following our resubmission to the FDA in 1H24

SAN DIEGO, Sept. 19, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. 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. ARS Pharma 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. Further, 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.

The PADAC meeting was held on May 11, 2023, and concluded a favorable benefit-risk profile of neffy, with a 16:6 vote in favor for adults and 17:5 vote in favor for children (≥30 kg) for the treatment of patients with allergic reactions (Type I), including anaphylaxis. In that session, no member of the Committee raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose neffy, which showed enhanced absorption during the time period when a clinical response would be expected.