EU Poised to Approve Neffy Epi Spray – Will U.S. Soon Follow?

By:
in Food Allergy, Food Allergy News
Published: July 6, 2024
Neffy Nasal Spray - - a needle-free epinephrine alternative.
Neffy epinephrine sprayer. Photo: ARS Pharma

The first nasal epinephrine spray for the treatment of allergic reactions is poised to become available in Europe in late 2024.

On June 28, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of EURneffy. That’s the European brand name of the new epinephrine spray developed by ARS Pharmaceuticals.

Richard Lowenthal, ARS Pharma’s CEO and president, calls the pending approval “a major milestone in the treatment of allergies.” He says the company can begin to market and sell the spray as soon as the European Commission gives final authorization. That’s expected in about 60 days.

Once that happens, EURneffy will be the continent’s first non-needle alternative to epinephrine auto-injectors for treating anaphylaxis.  

“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 outcome of allergic reactions,” Lowenthal says.

Status of Neffy in the U.S.

The nasal epinephrine spray is known as neffy in the United States. ARS Pharma’s quest to achieve U.S. Food and Drug Administration approval is moving ahead – and things are looking good, Lowenthal told Allergic Living in early July.

The FDA’s deadline to issue a decision on the company’s latest submission is October 2, 2024. Lowenthal and his team are hoping to hear from the FDA sooner on neffy.

“We’re really on the cusp of approval,” the CEO says. “We are just waiting for them to finish up the final parts of the labeling, and then it should be approved very quickly.”

The FDA has reviewed the additional study data requested in September 2023, which the company submitted in the spring of 2024. The results of that study were very positive, Lowenthal says.

The FDA has already agreed to final wording for neffy on the physician’s package insert. ARS Pharma is now waiting for FDA staff to sign off on final wording for the patient package insert.

Neffy: New FDA Study Results

In May 2023, an FDA advisory committee of independent experts endorsed approving the 2-milligram epinephrine spray for adults and children weighing 66 pounds or more. But in September 2023, the FDA surprised ARS Pharma, along with many in the food allergy community, by declining to approve neffy.

Instead, regulators asked for an additional study of how well two doses of the epinephrine spray worked in people with nasal congestion. (The company had previously submitted the results of a study on one dose of the nasal spray in people in nasal congestion.)

In April 2024, ARS Pharma submitted the results of the additional trial. It involved 43 healthy adult participants who had purified antigen (allergen) sprayed into their noses to provoke nasal congestion.

Participants received two doses of the epinephrine spray, either in the same nostril or in alternate nostrils. Researchers looked at changes in heart rate and blood pressure, which indicate epinephrine absorption.

The study found two doses of neffy resulted in greater heart rate and blood pressure changes than two doses of epinephrine given by syringe. In people with nasal rhinitis, spraying neffy twice in the same nostril led to greater blood pressure and heart rate changes than dosing once in each nostril.

Based on these results, neffy’s label will advise dosing in the same nostril if a second dose is needed to halt the reaction, Lowenthal says.

There were no serious adverse events reported in any of the clinical trials involving neffy. The most common side effects were mild nasal discomfort, reported by about 10 percent of participants, or mild headache, reported by 6 percent. 

After Epi Spray: ER or Not?

If the FDA does approve, there will be a difference in the usage instructions for neffy from current auto-injectors. Neffy’s label will likely not advise seeking “immediate medical or hospital care” after use in every case.

According to Lowenthal, the label will instead say: “The physician should recommend when it’s appropriate to seek emergency medical help” after using the sprayer.

This reflects updated allergists’ guidelines issued in February 2024 by the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology. The guidelines 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 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 one of the top reasons people gave for not using epinephrine when symptoms called for it was not wanting to have to go to the ER.

“The old, legacy language of EpiPen had statements that said, ‘in conjunction with use of this product, seek emergency medical help,’” Lowenthal says. That led to people waiting or not administering the auto-injector, he says. “Because they think if they administer it, they have to go to the emergency room.”

“We are thrilled” that the FDA agreed to update the advice, Lowenthal adds. “This is going to be really helpful to the community. If they use the epinephrine right away, they are going to have much better outcomes. It’s those delays and hesitation that causes those worse clinical outcomes or, God forbid, the deaths.”

Neffy and FDA Next Steps

In anticipation of FDA approval, ARS Pharma has already produced two lots of their nasal epinephrine sprayers. They have about 40,000 packages containing two doses ready to go, and will ramp up production quickly thereafter, Lowenthal says.

The company is also ready to launch a website where patients, caregivers and physicians will find help with requesting prior authorization of neffy from insurers. Prior authorization will be needed for insurance coverage until neffy is included on prescription formularies, which can take several months, Lowenthal says.

Patients will also be able to go onto the website to make an appointment with a telehealth provider, who can write a prescription for neffy.

When available, 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.

Nasal Spray for Smaller Children

ARS Pharma has also developed a 1 mg sprayer for kids 30 to 66 pounds. The company will request FDA approval of the lower dose right after the 2 mg neffy version is approved, Lowenthal says.

The FDA then has six months to issue a decision on the 1 mg dose. Lowenthal is hoping approval will come sooner, knowing that many parents will be eager for an epinephrine nasal spray option for younger children. “I’m hoping FDA will also review that quickly,” he says.

In addition to being able to market their nasal sprayer in the EU, the European Medicines Agency approval also clears the way for EURneffy to be sold in Norway and Iceland, though not in the United Kingdom.

Related Reading:
Advice to Always Go to the ER After Epi is Evolving
4 Epinephrine Auto-Injector Alternatives Making Progress