ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U.S. FDA for neffy (epinephrine nasal spray)

SAN DIEGO, Oct. 06, 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 United States (U.S.) Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) previously issued regarding its new drug application (NDA) for neffy (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

The Type A meeting with FDA will be held by the end of October.

“Patients and caregivers are waiting for neffy to be approved and have expressed to us disappointment with the delay in the FDA approval. We intend to work with FDA to meet the critical need for a needle-free epinephrine treatment as quickly as possible. Millions of people are at risk of a potentially life-threatening severe allergic reaction, and in practice, many are without any treatment option today, due to their inability to carry, or hesitancy or refusal to inject epinephrine in a timely manner. We are committed to meeting this urgent unmet medical need,” said Richard Lowenthal, Co-founder, President, and CEO of ARS Pharma. “We were surprised by the late decision of FDA to request an additional study, based on prior discussions with FDA that this study could be conducted post approval, as informative for labeling. We are moving rapidly to conduct the study and look forward to the Type A meeting, which will provide an opportunity to discuss the CRL and pathway forward with FDA.”

In May 2023, an FDA Advisory Committee (the Pulmonary-Allergy Drugs Advisory Committee (PADAC)) concluded a favorable benefit-risk profile and recommended approval of neffy. Multiple PADAC members highlighted the favorable profile of neffy in our completed single-dose nasal allergen challenge study, which showed enhanced absorption during the time period when a clinical response would be expected. No member of the Committee requested a repeat dose study with neffy during allergen-induced allergic rhinitis, and ARS Pharma aligned with FDA in May 2023 and re-confirmed in August 2023 that such a study could be completed as a post-marketing requirement and had also aligned on final physician labeling.