The Food and Drug Administration has approved ARS Pharmaceuticals’ neffy epinephrine nasal spray for severe allergic reactions. This makes it the first non-needle epinephrine treatment available in the United States for adults and older kids with food, sting or drug allergies.
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” said Dr. Kelly Stone. He’s associate director of the division of pulmonology, allergy and critical care in the FDA’s Center for Drug Evaluation and Research.
Stone, an allergist-immunologist, spoke of the potential for an epinephrine nasal spray to reduce barriers to using epinephrine promptly. “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” he said in a news release.
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies,” said Richard Lowenthal, ARS Pharma’s president and CEO. He called his company’s novel sprayer “a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety.”
In an interview, Lowenthal added: “We designed a product we hope people are going to use. They’re not going to hesitate; they will have peace of mind.”
Food allergy advocates welcomed the news of neffy’s approval with excitement across social media. In a statement, the food allergy nonprofit FARE commended the FDA for the approval. “This is a win for the food allergy community,” said Sung Poblete, PhD, FARE’s CEO.
The FDA approved the neffy epinephrine spray for adults and children over 66 pounds. It is administered as one 2-milligram spray in a nostril. Each neffy package has two epinephrine nasal sprayers. In a reaction that’s not resolving quickly, the second spray can be administered into the same nostril.
Studies Behind Neffy’s Approval
The FDA says neffy’s approval was based on four studies in 175 healthy adults, without anaphylaxis. The studies compared concentrations of epinephrine in the blood after using neffy and after administering an epinephrine auto-injector or a manual syringe.
The results from these studies showed comparable epinephrine blood concentrations between neffy and epinephrine injection devices. The FDA says neffy also showed similar increases in blood pressure and heart rate as the injection devices.
ARS’ research suggests children as young as 10 years old can use neffy by themselves. “The human factors study had kids down to age 10, and they all had no problem using the product at all. Nobody made an error,” Lowenthal told Allergic Living.
How to Get Neffy?
The CEO says ARS Pharma is ramping up production of the sprayers. He expects there to be widespread availability in pharmacies about eight weeks after the Aug. 9 approval date.
Because neffy isn’t yet included on prescription formularies, prior authorization will be needed for insurance coverage. Patients and caregivers can get help with that by registering on Neffy.com.
As of Sept. 4, patients and caregivers can pre-order the epinephrine sprayers through the “neffyconnect” program on Neffy.com. The website has two options. First, they can fill out a form and request a prescription for the device through their own physician. Secondly, they can schedule an appointment with a telehealth provider, who can write a prescription for neffy.
“We will be very transparent, through email and text, whatever they prefer, as to when drug will be available. Then we will know exactly when we can start shipping,” Lowenthal says.
Neffy Cost; Role for Stock Epi?
ARS Pharma says the cash 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.
FARE also suggests the convenience of a compact, needle-free device could lead to more placement of emergency epinephrine in public spaces.
“Importantly, we believe that innovation of this nature should also make it easier to have epinephrine more broadly available for use in the event of an emergency – in police cruisers, at restaurants, in airplanes, at hotels, at amusement parks and in other areas where accidental exposures are possible,” Poblete said.
Shelf Life and Storage
Neffy’s shelf life, or expiration date, is 30 months. Auto-injectors typically expire after 12 to 18 months.
Neffy is also stable at higher temperatures than epinephrine in auto-injectors. ARS Pharma’s research finds the medication can be stored at up to 122 degrees Fahrenheit for up to three months and still maintain much of its potency.
However, it’s still recommended that neffy be stored room temperature, between 68 and 77 degrees F. The label says, “storage at high temperatures of up to 122 degrees Fahrenheit is allowed for a few days.”
“We want people to be comfortable that if they leave it in their car, they don’t have to be worried that their medication isn’t going to work,” Lowenthal says.
The label advises against freezing. However, Lowenthal says patients should not worry if they accidentally leave it in their car overnight in the winter and allow it to return to room temperature afterwards.
ER May Not Be Needed
In another difference from injected epinephrine, neffy’s prescribing information advises doctors to counsel patients on “when it’s appropriate to seek emergency medical care” after using the sprayer.
Long-standing auto-injector prescribing information advises to “go immediately to the nearest emergency room for further treatment of anaphylaxis.” But updated allergists’ practice guidelines, issued in February 2024, now say that if anaphylaxis symptoms resolve quickly after using epinephrine auto-injector, in many cases it’s safe for a patient to remain at home. They don’t need to call 911 or head to the ER.
There are exceptions – such as if a patient doesn’t have a second auto-injector on hand in case symptoms return. And, patients should also still call 911 if their symptoms are severe or if symptoms don’t go away completely or nearly completely.
Lowenthal says his company’s research found that not wanting to have to go to the ER was one of the top reasons people gave for not using epinephrine even when symptoms called for it. He views having an FDA-approved label that’s in line with the most current allergists’ advice as “a huge win.”
Neffy’s Approval in Younger Kids, Europe
ARS Pharma plans to submit a supplemental new drug application to the FDA in the coming weeks for approval of a 1 mg sprayer for children weighing 30 to 66 pounds. The FDA will then have six months to make its decision. “We’re hoping it’s sooner than that,” Lowenthal says.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recommended approval of EURneffy. That’s the European brand name of ARS Pharma’s 2 mg sprayer. [Update: the EU approved EURneffy in late August 2024. See article.]
The pediatric committee of the European agency has requested the company conduct studies in even smaller children. They want to know about an epinephrine spray for young kids weighing 15 to 30 pounds, and as young as a year-old. Toddlers of that size will likely need a dose of even less than 1 mg.
To do these studies, the company will modify the nasal sprayer device to accommodate their smaller noses. Those trials will likely take place in 2025, Lowenthal says. The company will request approval of the dose for the smallest kids in the U.S. as well.
The most common side effects of neffy are mild and include throat irritation, headache, nasal discomfort, nasal discomfort, feeling jittery and runny nose.
Type I allergic reactions result in an estimated 500,000 emergency room visits each year. Nearly 60 percent of patients did not receive epinephrine prior to hospital arrival, according to ARS Pharma research.
Last updated September 4, 2024 re pre-ordering.
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