Dr. Michael Blaiss, an allergist at the Medical College of Georgia, was often surprised by how hesitant his patients were to use their auto-injectors, syringe-like devices like the EpiPen that deliver a drug needed to head off potentially fatal allergic reactions.
Some patients called his office, on the verge of shock, to double-check that it was necessary to give themselves the shot. Others told him they would rather wait in the emergency room parking lot to “see what happens.”
Children suffering dangerous reactions sometimes ran away from their parents, terrified of the needle. One Tom-and-Jerry-like chase ended with a father getting mistakenly injected, Dr. Blaiss recalled.
A new device recently approved by the Food and Drug Administration may help quell some of the anxiety. The device, Neffy, administers epinephrine, the drug in the EpiPen, through a nasal spray rather than a needle.
“We have needed this for so long,” Dr. Blaiss said. “I truly believe it will save lives.”
Patient advocates and allergists, who regularly see the consequences of needle aversion, have been awaiting an auto-injector alternative for years. Among the general population, this fear is relatively common — most children and up to 30 percent of young adults are afraid of needles, according to one systematic review.
Ilana Golant, founder and chief executive of the Food Allergy Fund, said she knew parents who had been so nervous to give the shot that they had missed the window to stave off a serious reaction, landing their child in the hospital.
Dr. Jonathan Spergel, an allergist at the Children’s Hospital of Philadelphia, said he became so concerned that some of his own patients wouldn’t use a needle in an emergency that he had them inject themselves at his office to show them it was “not so bad.”
There are many other reasons patients might prefer the nasal spray, even if they aren’t afraid of needles. For one, the Neffy nasal spray is relatively small — just over two inches tall — which makes it more convenient to carry around than a clunky, six-inch EpiPen, Dr. Blaiss said.
His patients rarely carry two EpiPens, which is advised in case the first dose of epinephrine is not sufficient, he said: “Now, with something this small, it really isn’t that hard.”
Neffy, expected to be widely available by the end of September, will also be relatively inexpensive for most insured patients, said Richard Lowenthal, chief executive of ARS Pharma, the device’s developer.
He said the company intended to cap out-of-pocket costs for two single-use nasal sprays, one prescription’s worth, at $25 for most people with commercial insurance and $199 for people with high-deductible plans or no insurance.
The nasal spray has a shelf life of about two and a half years, which means patients may replace it less often than they would replace an EpiPen, which typically expires 18 months after it is manufactured.
Still, Neffy might not be the right choice for some patients.
Many young children are still ineligible for the nasal spray, as it is only approved for adults and children who are heavier than 66 pounds. The company expects the device will be available for children heavier than 33 pounds before next summer, Mr. Lowenthal said.
Dr. Spergel said patients also had to consider whether they were comfortable with the very limited clinical data on how well Neffy works in people experiencing anaphylaxis. Some may prefer to stick to the EpiPen or a generic version of the auto-injector, which is “tried and true.”
Treatments for severe allergic reactions cannot be put through randomized clinical trials — researchers can’t induce a life-threatening reaction and give half of the group a placebo treatment.
Instead, researchers administered the nose spray to healthy subjects who were not having allergic reactions and compared their reactions to those of similar participants who received epinephrine injections.
The investigators found that the concentration of epinephrine in the blood and subjects’ heart rate and blood pressure — all indications that the drug has been absorbed into the body — were consistent between the groups, suggesting that the spray is similarly effective.
They conducted these trials again in people with nasal congestion and reached similar conclusions. And a small clinical study at a Japanese clinic found that the spray was effective at treating allergic reactions in 15 children who were undergoing food allergy testing.
The results from these studies suggest that Neffy should work just as well as an auto-injector. But Dr. Blaiss said it would be hard to know with any certainty until people started using it to treat anaphylaxis outside a medical setting.
He said he would advise patients who have had severe allergic reactions to carry an EpiPen as a backup option.
“We don’t know until it gets into the real world, so I do think we have to be cautious, at least at the beginning,” Dr. Blaiss said.
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