The FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) voted at its May 11, 2023 meeting in support of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, the company announced. Committee members voted 16-6 that the data supported a favorable risk/benefit assessment for use in adults and 17-5 for pediatric use. The FDA accepted ARS’ NDA for Neffy in October 2022 and set a PDUFA goal date in mid-2023.
Neffy is delivered via Aptar Pharma‘s Unidose (UDS) device, which the company points out is the delivery device for 6 products that have already been approved by the FDA, including Narcan naloxone nasal spray.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “We’d like to thank PADAC members for their robust scientific discussions and clinical perspectives. The committee’s thoughtful review of the data, and support of the potential for Neffy to address significant unmet needs of the severe allergy community, if approved, is highly encouraging. We believe our clinical data from more than 600 individuals demonstrate Neffy absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free and conveniently sized. We are committed to making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with using a needle-based device.”
Lowenthal added, “Millions of people have been waiting decades for a new delivery method of epinephrine, and we are grateful to the community for sharing their personal experiences and illustrating the potential Neffy has in changing lives. We continue discussions with private payers, pharmacy benefit managers, and retail pharmacies to ensure that if Neffy receives FDA approval, we are ready to make this important new treatment modality widely available for those who need it.”
Read the ARS Pharmaceuticals press release.
