Epinephrine Nasal Spray Now Available as Only Non-Injectable Treatment of Anaphylaxis

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An announcement was made by ARS Pharmaceuticals, Inc., that the epinephrine nasal spray (neffy) has now been made available nationwide by prescription following the July approval by the US Food and Drug Administration (FDA) of 2 mg of this drug for those with Type I allergic reactions such as anaphylaxis.¹,²

Epinephrine is currently the only approved treatment for Type I severe allergic reactions, which are frequently life-threatening. The drug represents the first and only syringe-free alternative to epinephrine injections like the EpiPen, and was approved for both adults and children with such conditions who weigh 30 kg or more.

“The introduction of neffy as the first and only needle-free treatment option for patients and caregivers living with severe allergic reactions marks a turning point for ARS Pharmaceuticals and the severe allergy community,” Eric Karas, chief commercial officer of ARS Pharmaceuticals, said in a statement. “Since approval, we have been partnering with healthcare providers, payers, and patient advocates to ensure access for patients.”¹

While the effectiveness of epinephrine auto-injectors is well-known, many individuals delay their use given concerns over needles, safety, portability, and their general complexity. The new epinephrine nasal spray was crafted with the aim of addressing such limitations, giving patients a needle-free alternative for ease of use during emergencies.

The nasal spray is given to patients in a single-dose into 1 nostril. Another dose may also be administered to patients in the same nostril provided their symptoms do not show improvement.²

As of September 23, the epinephrine nasal spray will be stocked among national retail pharmacies. The announcement by ARS notes that there is an available $25 co-pay savings card on neffy.com for eligible individuals to use at pharmacies.¹

Due to the partnership between BlinkRx and the neffyConnect program, patients deemed eligible who also have commercial insurance may be given 2 single-use epinephrine nasal spray devices for $25 with a co-pay savings plan in use. ARS Pharmaceuticals is offering, for individuals without insurance or coverage of the device, a cash price of $199 for the same 2 devices.

Those deemed to qualify for the ARS Patient Assistance Program are also permitted to be given the nasal spray free of charge. To request the spray through their current provider or via a virtual consultation with a clinician, either an appointment with one’s provider or a visit to neffy.com should be made.
Services are supported through neffyConnect, a program also providing access support and financial help. The announcement by ARS Pharmaceuticals also notes that the company is giving free carrying cases which can hold 2 nasal spray devices, in addition to instructions, for insurance of easy access.

The company also plans to provide the product, named EURneffy in Europe, on an international basis. An approval was given by the European Commission for EURneffy on August 22, 2024, the emergency treatment of those with allergic reactions within the EU. Availability of the product is slated for select EU countries by the fourth quarter of 2024.

“The introduction of neffy is welcomed by the healthcare community,” Carlos Camargo, MD DrPH, professor of emergency medicine at Massachusetts General Hospital and Harvard Medical School, said in a statement. “(Epinephrine nasal spray) changes the paradigm when it comes to treatment options for patients and families living with severe allergic reactions — and the way in which healthcare providers practice.”¹

Camargo added that the drug may provide patients a fast and easy-to-carry, easy-to-use needle-free option which he hopes will result in greater adherence to treating allergic events.

References

1. ^{ARS Pharmaceuticals Announces U.S. Availability of neffy® (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. ARS Pharma. September 23, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-us-availability-neffyr-epinephrine. Date accessed: September 23, 2024.}
2. ^{Smith T. FDA Approves Epinephrine Nasal Spray for Emergency Treatment of Allergic Reactions. HCPLive. August 9, 2024. https://www.hcplive.com/view/fda-approves-epinephrine-nasal-spray-for-emergency-treatment-of-allergic-reactions. Date accessed: September 23, 2024.}