FDA approves Neffy, a nasal spray alternative to an EpiPen that does not need a needle to stop an allergic reaction

Those at risk of a severe allergic reaction always have handy an EpiPen just in case. But soon their life might be saved by a spray in the nose rather than a needle to the thigh.

Last week the FDA approved Neffy, an epinephrine nasal spray, for use in emergency allergic reactions for kids and adults.

Retired allergist at the Northwest Asthma & Allergy Center Paul Williams said the spray “certainly has the potential” to become the preferred delivery of the drug over an autoinjector, commonly known as an EpiPen.

“A big advantage to this product is that it is not a shot. A lot of people don’t use their autoinjector out of fear of the needle, even when it could save their life. That is especially true for children with allergies who may be afraid of needles,” Williams said.

According to the FDA announcement, the nasal spray is the first epinephrine product that is not administered by injection.

“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need,” said FDA Center for Drug Evaluation and Research associate director Kelly Stone in a statement.

While most allergic reactions are minor and go away on their own, anaphylaxis is a severe allergic reaction that can be life threatening. These serious symptoms typically present themselves within minutes of exposure to certain foods, medications or insect stings that can cause anaphylaxis.

In these allergic reactions, the constriction of airways cause wheezing, shortness of breath and the inability for air to reach the lungs. Epinephrine relaxes these airways, reduces swelling and allows blood to flow normally. According to Williams, anaphylaxis is typically only fatal because of a delay of epinephrine being applied. For that reason, those at high risk of these reactions usually carry epinephrine in the form of a large autoinjector that is put into the thigh.

Neffy is sprayed into one nostril in a single dose – similar to other nasal sprays like Narcan. A second dose can be administered in the same nostril if symptoms worsen or don’t improve.

ARS Pharmaceuticals, the company that developed Neffy, said in a statement they hoped the nasal spray could be an alternative to those who want to avoid injecting epinephrine.

“A treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many – our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed,” ARS Pharmaceuticals CEO Richard Lowenthal said in a statement.

According to the FDA, Neffy was approved based on the results of four studies of 175 healthy adults, which found epinephrine measured in the blood at adequate rates. Importantly, these test subjects were not in anaphylaxis when tested – a life-threatening emergency that cannot be observed in laboratory conditions.

For this reason Williams believes that for the time being Neffy should be seen as an addition to an EpiPen, rather than a replacement.

“At this point we don’t know for sure if any limitations from this drug will become apparent with actual anaphylactic cases,” he said – calling for the spray to be used as a “backup” to an autoinjector. “Hopefully we’ll get that experience over a one or two year period.”

One possible limitation is if anaphylaxis causes their nose to swell, Neffy may become less effective, Williams said. Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption.

It is often recommended those with severe allergies carry two EpiPens. Having an autoinjector and a nasal spray instead could be more convenient, he said.

“This spray is a somewhat smaller device, so it can more easily be carried by a lot of adolescents and older children who don’t always carry their EpiPens. Because it’s a little bit bulky, particularly if you have to carry two,” he said.

Neffy is approved for children and adults who weigh at least 66 pounds. Schools and many other public spaces that accommodate children have EpiPens in stock for emergencies. It remains unclear if Neffy could supplement schools’ autoinjector supply.

In a statement, a Washington Department of Health spokesperson said their agency would be announcing a new statewide standing order on epinephrine that includes Neffy. The new rules will make it easier for schools to obtain the drug, the statement read.

Spokane Public Schools has 1,194 students with an epinephrine plan on file. In a statement, Executive Director of School Support Services Rebecca Doughty welcomed the addition of Neffy as an option for schools.

“Our nurses are always prepared to utilize whatever medication the student’s provider has ordered and are comfortable doing so. A medication that can be delivered nasally instead of via needle will always be preferable for a child,” she said.

According to ARS Pharmaceutical, Neffy will be available within eight weeks of the FDA approval. With commercial insurance a prescription of two single-use Neffy devices should cost a $25 copay, according to the organizations. Without insurance Neffy will cost $199 for two doses. Each dose of Neffy lasts for 30 months.