ARS Pharmaceuticals expects to launch neffy (epinephrine nasal spray) in H2 2024, for which the company plans to submit a response to the complete response letter (CRL) issued by the US Food and Drug Administration (FDA) in September 2023.

The US agency requested a pharmacokinetic (PK) /pharmacodynamic (PD) study to be conducted that would compare repeat doses of neffy to an intramuscular epinephrine injection in allergen-induced allergic rhinitis conditions (nasal congestion), before approving neffy as treatment of Type 1 allergic reactions. The decision was a complete turnaround from the FDA’s earlier communication that the repeat dose study was to be conducted as part of post-market surveillance.

Last month, ARS reported topline data from the repeat dose study, as requested by the FDA, showing that PK and PD profile for neffy was greater than or similar to an intramuscular epinephrine injection. Dosing neffy in the same nostril (R/R) resulted in higher PD than the injection at all time points measured, while dosing in the opposite nostril (R/L) was higher than injection until the 40 to 60-minute time points, after which PD was indistinguishable from the injection.

The company added that although the “FDA did not provide guidance on a prespecified set of endpoints, but the data are anticipated to be informative to labelling if a second dose of neffy is needed”. The results from the trial will support the response letter to the FDA. The company plans to file the response by Q2 followed by a six-month review period, with an FDA action date and potential launch expected in H2 2024.

Neffy is currently under review for approval by the European Medicines Agency (EMA), with a decision expected by mid-2024. ARS also plans to file for regulatory approval in other countries in 2024. According to a GlobalData analysis, neffy is expected to generate $353m in global sales in 2029.

GlobalData is the parent company of Clinical Trials Arena.

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ARS is also investigating neffy as a potential treatment for urticaria or hives. The company plans to start an outpatient urticaria study in patients who experience frequent acute flares despite treatment with antihistamines by the end of this year.

Last month, the Phase II trial (NCT05496465) evaluating neffy in patients with chronic spontaneous urticaria met its primary endpoints by demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores.

ARS also reported cash reserves of $228.4m, which are expected to fund operations for the next three years. The company has a market cap of approximately $864m.