Editor's note: This story has been updated to incorporate details on availability and pricing.
August 9, 2024 – An adrenaline nasal spray for the treatment of severe allergic reactions possibly soon available within the US
The FDA announced The nasal spray called Neffy was approved on Friday. It is meant for adults and kids weighing at the least 30 kilograms that suffer from so-called type 1 allergies, which include the doubtless life-threatening disease anaphylaxis. Signs include difficulty respiratory or swallowing, skin symptoms comparable to hives and swelling, stomach problems comparable to cramps or nausea, and heart problems comparable to a drop in blood pressure and heart palpitations.
Allergic reactions are brought on by an abnormal response of the immune system, often to something like Eat or medications or an insect bite. Until now, the one treatment for anaphylaxis was an adrenaline injection within the thigh, often through a automatic injection pen like the EpiPen. It is estimated that up to 2% of people in the United States are at risk of suffering an anaphylactic shock during their lifetime.
Neffy's maker, ARS Pharma, expects the drug to be available within 8 weeks. For patients with private health insurance, Neffy costs $25 for two disposable devices. For patients without insurance, or for those whose insurance does not cover Neffy, ARS is offering it for a cash price of $199. Patients without insurance who have exhausted all other options could get it for free, the company said in a statement.
Neffy is sprayed into one nostril as a single dose. A combination of four studies involving 175 healthy adults showed that the product could achieve blood adrenaline levels similar to those achieved by a shot, as well as a similar increase in blood pressure and heart rate. In a study involving children weighing more than 30 kilograms, blood concentration levels after taking Neffy were similar to those seen in adults using the product.
If a person's blood pressure drops too low, they may go into anaphylactic shock, and swollen bronchial tissue can lead to unconsciousness. Anaphylactic shock requires immediate life-saving treatment.
The FDA recommends that people with certain nasal conditions or a history of nasal surgery discuss with their doctor whether they should use Neffy. Additionally, the product may not be safe for some people with certain other medical conditions or a sulfite allergy.
In a previous announcement by ARS Pharma regarding its efforts to obtain FDA approval for Neffy, the importance of providing a needle-free treatment option was emphasized.
“Although adrenaline auto-injectors have been shown to be extremely effective, there are well-documented limitations that lead many patients and caregivers to delay or not provide treatment in an emergency situation,” The company said.
These limitations include fear of needles, lack of portability, safety concerns, and more.
The company said there are about 40 million people within the United States that suffer from Type 1 reactions, and only 3.2 million of them had a prescription for an epinephrine injection pen last 12 months.
“Even when patients or caregivers carry an auto-injector, more than half delay administering the device in an emergency or do not administer it at all,” the corporate said.