The European Commission has approved EURneffy, the continent’s first nasal epinephrine spray for the treatment of severe allergic reactions.
ARS Pharmaceuticals makes the nasal spray, known by the brand name neffy in the United States. It is the first non-needle epinephrine treatment for adults and children with food, insect venom and drug allergies.
With the approval, “we’re getting ready to launch in Europe,” says Richard Lowenthal, ARS Pharma’s president and CEO.
“EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf life may increase the likelihood that patients will both carry and administer adrenaline, which improves the outcome of allergic reactions,” the CEO says.
In Europe, the nasal sprayer will first become available in Germany in late 2024, Lowenthal tells Allergic Living.
Each EU country negotiates pricing with drugmakers individually. So Lowenthal says the timing of EURneffy’s availability in other countries will depend on how quickly ARS Pharma can reach those agreements.
Neffy Response in the U.S.
The late August EU approval comes just two weeks after the Food and Drug Administration approved neffy in the United States. Since then, ARS Pharma has been deluged with thousands of inquiries from families and patients, Lowenthal says. “We are getting a fairly overwhelming response.”
“Being needle-free is a major advantage that makes people feel more comfortable about treating themselves quickly and carrying the device,” he says.
Another benefit: Neffy’s shelf life, or expiration date, is 30 months. By comparison, epinephrine auto-injectors expire after 12 to 18 months.
Inquiries have come from school nurses’ organizations wanting to be prepared for the new school year. Lowenthal says that, unlike auto-injectors, the nasal epinephrine sprayer does not require special training.
Police and fire departments have also expressed interest in adding neffy to emergency kits. Neffy uses the same sprayer device as naloxone (the brand Narcan), used to reverse opioid overdoses. Many first responders are familiar with using Narcan.
“They know from the Narcan experience that neffy is something they can keep in their emergency kit for when they are called to an anaphylactic emergency,” Lowenthal says.
“Neffy makes it possible that non-medical professionals can use it easily in emergency situations.”
EURneffy Studies, Status in U.K.
On June 28, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the 2 milligram EURneffy dose. That dose is for adults and children weighing 66 pounds or more.
The EMA approval was based on 14 clinical trials that included 537 healthy people aged 19 to 55. The trials compared EURneffy with epinephrine administered manually using a syringe, or using an auto-injector.
“The results demonstrate that the effects in the body of nasally-administered adrenaline are comparable to products given by an intramuscular injection,” EMA stated.
The European Commission sign-off was the final step in the regulatory process there. The EU approval also clears the way for EURneffy to be sold in Norway and Iceland.
As for the United Kingdom, ARS Pharma plans to submit for approval in November 2024 and is expecting a decision in March 2025, Lowenthal says. They have also been in touch with regulators in Canada and hope for an expedited review and an approval in Canada by summer 2025.
Update: Getting Neffy in the U.S.
Lowenthal says ARS Pharma is working quickly to get neffy into U.S. pharmacies. There should be widespread availability by the end of September.
American patients and families will then have two options for how to get the medication. They can either get it from their usual pharmacy, or they can order it through it the company’s website, called neffy.com.
Starting on Sept. 3, patients and families can go to neffy.com to request an appointment with a telehealth provider, who can write a prescription for neffy. Patients can of course also request a neffy prescription from their own doctor.
On the website, ARS Pharma will also request prior authorization from the patient’s insurer. Prior authorization will be needed for insurance coverage until neffy is added to prescription formularies, which could take 6 to 9 months, Lowenthal says.
Neffy prescriptions ordered through the website will be delivered by mail from an online pharmacy.
The cash pay price for a pack of two neffy sprayers will be $199. With coupons, most people with commercial insurance will pay about $25. There will also be a program offering free medication for people below certain income thresholds.
Epi Spray for Smaller Kids
ARS Pharma has also developed a 1 mg sprayer for kids 30 to 66 pounds. The company plans to apply for FDA approval of the lower dose in the next few weeks, Lowenthal says. The FDA will then have six months to issue a decision on the 1 mg dose.
Related Reading:
FDA Approves Neffy Epinephrine Sprayer
How Does Epinephrine Turn Off an Allergic Reaction?
