ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which compared 2 doses of Neffy to 2 doses of intramuscular epinephrine, demonstrate that Neffy’s PK and PD profiles are comparable or superior to injected epinephrine under the challenge conditions. The company said that it also performed the nitrosamine testing requested in the CRL and was unable to detect nitrosamines.
The repeat dose study enrolled 43 seasonal allergic rhinitis patients and compared repeat doses of Neffy in the same nostril, repeat doses of Neffy with one dose in each nostril, and repeat doses of intramuscular injection of epinephrine using a manual syringe per the FDA’s request. Dosing was completed with and without nasal allergen challenge. ARS notes that when the second dose of Neffy was sprayed in the same nostril as the first, exposure was greater than one dose in each nostril and greater than injected doses at all time points.
ARS President and CEO Richard Lowenthal commented, “We are very pleased with the topline results from our repeat dose study of Neffy under nasal allergen challenge conditions, which we believe will address FDA’s requests in their complete response letter and support the approval of Neffy for the treatment of Type 1 allergies, including anaphylaxis. . . .With these results, we are completing the necessary work to submit our response to FDA in the next couple of months. We look forward to working with the agency in our efforts to make Neffy available to patients as soon as possible.”
ARS also said that study data will be submitted to the EMA and that it expects a decision from the Committee for Medicinal Products for Human Use (CHMP) Opinion by the middle of the year. ARS submitted an MAA for Neffy in 2020. The company reacquired the European rights to the nasal spray from Recordati in February 2023.
Read the ARS Pharmaceuticals press release.
