According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a PK/PD repeated-dose study prior to approval. The CRL also asked for more information on nitrosamine impurities, which the company says it “does not believe . . . would be a rate-limiting step for its resubmission to the FDA.”
The FDA accepted the NDA for Neffy in October 2022, and the Pulmonary-Allergy Drug Advisory Committee (PADAC) voted in support of approval at in May 2023. In June 2023, the FDA said that it was extending the PDUFA date for the Neffy application until September 19.
ARS says that it was “aligned with FDA in August 2023 on both physician labeling and post-market requirements,” which included a repeat-dose study of Neffy in people with allergic rhinitis. Because it was already planning to conduct the study, ARS said that it expects to be able to resubmit the application by mid-2024. The company also said that it plans to formally appeal the CRL.
ARS Pharma President and CEO Richard Lowenthal commented, “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive advisory committee vote. In fact, multiple committee members highlighted the favorable profile of Neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response period, is of no concern.”
Lowenthal added, “We stand by the totality of the Neffy data package generated in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions. . . . Patients and caregivers are waiting for Neffy, and we aim to complete the newly requested trial as quickly as possible to meet the needs of patients.”
The EMA accepted ARS’s MAA for Neffy review in October 2020. The company says that it expects that review to be complete in early 2024 and that it expects to submit marketing applications for Neffy in additional countries in 2024.
Read the ARS Pharma press release.
