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ARS Pharmaceuticals Says FDA Schedules Type A Meeting For Neffy By The End Of October
(RTTNews) - Biopharmaceutical company ARS Pharmaceuticals, Inc. (SPRY) announced Friday that the 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. The company said it intends to work with FDA to meet the critical need for a needle-free epinephrine treatment as quickly as possible.
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.
Clinical data from a rigorous registration program of more than 600 subjects demonstrated that neffy achieved both a pharmacokinetic (PK) and pharmacodynamic (PD) profile that is comparable to approved injection products as well as a safety profile that is well-tolerated, but without needle-related risks.
The company plans to complete a repeat dose study with neffy in allergen-induced allergic rhinitis and file its NDA resubmission to the FDA in the first half of 2024, with an anticipated launch of neffy, if approved, in the second half of 2024.
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