The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the treatment of Type 1 Allergic Reactions, including anaphylaxis in adult and paediatric patients who weigh at least 30kg.
The approval makes epinephrine nasal spray the first and only needle-free treatment option for patients and families with severe allergic reactions.
ARS Pharmaceuticals co-founder, president and CEO Richard Lowenthal said: “This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many.”
The FDA approval is supported by data from five primary registration studies using a 2mg intranasal dose of epinephrine. Numerous pilot and supportive studies complemented these main trials.
Neffy achieved all its clinical endpoints, with its pharmacokinetic (PK) and pharmacodynamic (PD) data falling within the range of approved epinephrine injection products.
The data set included studies involving single and double doses administered to healthy adults and self- and caregiver administration in Type 1 allergy patients, paediatric patients weighing ≥30 kg, and those with allergic rhinitis.
FDA’s Center for Drug Evaluation and Research pulmonology, allergy and critical care division associate director Kelly Stone said: “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.
“As a result, neffy provides an important treatment option and addresses an unmet need.”
Neffy is anticipated to be available in the US within eight weeks of FDA approval for patients weighing 30kg or more.
ARS Pharma plans to submit a supplemental New Drug Application (NDA) application for neffy for children weighing between 15kg and 30kg by the end of Q3 2024.
In the European Union (EU), the spray received a positive opinion from the Committee for Medicinal Products for Human Use in June. The commercial launch is expected in Q4 2024, following the anticipated market authorisation by the European Commission.
