ARS Pharmaceuticals announced that it has submitted marketing applications for neffy epinephrine (adrenalin) nasal spray in Canada and in the UK. The nasal spray has been approved in the US and in Europe (as EURneffy) for the treatment of anaphylaxis in adults and in children weighing ≥30 kg since August 2024. In November 2024, ALK-Abelló acquired the rights to market neffy in much of the world except the US, Australia, New Zealand, Japan, and China and said that it intended to launch the product first in Canada and Europe.
In addition, ARS Pharma said it intends to initiate a Phase 2b trial of ARS-2 intranasal epinephrine for the treatment of flare-ups in patients with urticaria early this year and pointed out that the deal with ALK would cover that indication as well as the anaphylaxis indication. The company reported positive results from a Phase 2 trial of the nasal spray for urticaria in February 2024.
ARS Pharma President and CEO Richard Lowenthal commented, “Building upon the approval of neffy in the US and Europe for the emergency treatment of severe allergic reactions, we are committed to helping facilitate access to this life-saving treatment worldwide. With submission in Canada and the UK, ARS Pharma now has approval or has filed for approval in jurisdictions comprising more than 98 percent of the current world market for epinephrine. We look forward to hearing from the regulatory agencies following their review of the applications.”
Read the ARS Pharma press release
