ARS Pharmaceuticals Announces FDA Type A Meeting to Discuss Neffy® Drug Application

ARS Pharmaceuticals, a biopharmaceutical company dedicated to protecting patients from severe allergic reactions, has announced that the United States Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) regarding its new drug application (NDA) for neffy® (epinephrine nasal spray). Neffy is intended for the treatment of allergic reactions, including anaphylaxis.

The Type A meeting, which will be held by the end of October, aims to address the delay in FDA approval for neffy. ARS Pharmaceuticals is committed to working with the FDA to meet the urgent need for a needle-free epinephrine treatment as quickly as possible. Many patients are currently without any treatment options due to their inability to carry or administer epinephrine injections in a timely manner.

In May 2023, an FDA Advisory Committee recommended the approval of neffy, highlighting its favorable benefit-risk profile. However, the FDA later requested an additional study, which ARS Pharmaceuticals plans to conduct rapidly. The company intends to complete the study and file its NDA resubmission to the FDA in the first half of 2024, with an anticipated launch of neffy in the second half of 2024.

Neffy offers a needle-free alternative for patients with severe allergic reactions, addressing limitations associated with epinephrine autoinjectors. Currently, a significant number of patients do not fill their epinephrine prescriptions, and even those who have the medication often do not carry or use it when needed. Neffy aims to provide a more accessible and user-friendly treatment option.

ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect patients from life-threatening anaphylaxis. The company’s focus on addressing the unmet medical need for effective and convenient epinephrine treatment demonstrates its commitment to improving the lives of millions of people at risk of severe allergic reactions.

For more information about ARS Pharmaceuticals and neffy, please visit www.ars-pharma.com.