ARS Pharmaceuticals announced that a Phase 2 trial of Neffy epinephrine nasal spray in patients with chronic spontaneous demonstrated that 1 mg and 2 mg doses of the intranasal epinephrine both produced statistically significant and clinically meaningful improvement in symptoms such as hives and itchy skin as soon as 5 minutes post dose. The inpatient study of Neffy, which enrolled 18 patients whose urticaria symptoms were not controlled with antihistamines or Xolair, found no significant difference in efficacy between the 1 mg dose and the 2 mg dose, the company said.
According to ARS, the company now intends to initiate a placebo-controlled study in urticaria patients by the end of this year, with the possibility of a pivotal efficacy study to follow in 2025. The company has been developing Neffy for the treatment of allergic reactions, including anaphylaxis, and notes that a pivotal study of the nasal spray for urticaria would follow potential approval of Neffy for allergic reactions.
ARS submitted an NDA for that indication in 2022, and the FDA issued a complete response letter to the application in September 2023. ARS recently announced results from a repeat dose study of Neffy that it plans to submit as part of its response to the CRL.
ARS Pharma Chief Medical Officer Sarina Tanimoto commented, “This study adds to the wealth of data supporting the efficacy and safety of Neffy in the treatment of Type 1 allergic reactions. Urticaria is not only a standalone Type 1 allergy disease, but also represents the most frequent symptom observed during Type 1 allergic reactions including anaphylaxis. The improvement in urticaria symptoms almost immediately after dosing Neffy demonstrated its rapid onset of action, and is consistent with the previously reported responses on pharmacodynamic markers of efficacy in as little as one minute after dosing.”
Read the ARS Pharmaceuticals press release.
