EU Regulators Approve First and Only Adrenaline Nosal Spay for Emergency Treatments

EU Regulators Approve First and Only Adrenaline Nosal Spay for Emergency Treatments

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The European Commission has approved the first and only no-needle adrenaline-based nosal spray, EURneffy®, to treat severe cases of allergenic reactions commonly known as anaphylaxis.

Developed by ARS Pharmaceuticals, Inc., the nosal spray offers EU residents living with severe allergic reactions the first alternative method for adrenaline delivery in over 30 years.

The decision announced by the commission on August 22 followed a similar FDA approval of the medication on August 9, 2024, allowing the spray to be commercially available on the US market.

Following the approval of EURneffy®e, Richard Lowenthal, Co-Founder and CEO of ARS Pharmaceuticals, said the commission’s decision marks a significant moment for Eu residents living with the medical condition.

Lowenthal added that the needle-free adrenaline spray is smaller and features a long shelf life and less temperature sensitivity, making it easy for patients to carry and administer the adrenaline, improving the medication outcome.

ARS Pharmaceuticals received the marketing authorization following a review of data for an extensive nosal spray program involving over 1,200 administrations and more than 700 study participants, as well as studies focusing on certain tests.

Eight-year Protection and Patents Validity

The approval grants EURneffy eight-year data protection, preventing any other applicant from relying on the data presented by ARS Pharmaceuticals during the EURneffy marketing authorization application.

The company will also enjoy ten years of protection from competitors who want to place generic, hybrid, or biosimilar products on the EU market until the expiration of the protective patents in 2039.

The anticipated adrenaline-based spay will be available in certain EU countries in the fourth Quarter of 2024, leveraging the startups already established markets in Europe.