EpiPens can (and do) save lives, but if you or your child (or your spouse, or whomever you’re injecting) has a phobia around needles, the injector can be difficult or even traumatizing to use. Enter neffy, a nasal epinephrine spray that provides the same protection as the EpiPen but in a needle-free form. The spray, which is designed to treat severe allergic reactions, is currently waiting on an FDA approval that is scheduled to come this month.
In May, an expert advisory panel recommended that the FDA approve neffy, voting 16 to 6 in favor of approving it for adult use and 17 to 5 in favor of approval for children weighing 66 pounds or more. The FDA was scheduled to make its approval decision on the nasal spray in June, but extended its deadline to September to allow for discussions of “labeling and post-marketing requirements,” according to a press release from ARS Pharmaceuticals, which developed the product. Post-marketing requirements typically refer to “activities after FDA approval of a product to generate additional data about a product’s safety, efficacy or optimal use,” an ARS spokesperson told Allergic Living in June.
ARS describes neffy as a “needle-free, low-dose intranasal epinephrine nasal spray,” designed to be used as a “rescue medication” for people with Type 1 severe allergic reactions. That includes anaphylaxis, a life-threatening allergic reaction that occurs when the body is exposed to an allergen and goes into shock, according to Mayo Clinic. Anaphylaxis must be treated immediately, ideally with epinephrine (aka adrenaline) and a follow-up trip to the emergency room.
The EpiPen and EpiPen Jr. (for kids), auto-injectors that contain epinephrine, are currently used to decrease these kinds of severe allergic reactions. EpiPens inject epinephrine directly into the muscle, using a needle that many people (especially kids) find frightening and even traumatic, according to many patient and parent testimonies during the advisory panel meeting in May.
A 2011 study of over 14,600 patients with EpiPens found that only 11 percent refilled their EpiPen prescription “consistently at all expected refill times.” A subsequent 2021 survey on EpiPen underuse found that caregivers are often hesitant to use the injector for a number of reasons, including their own fear of the child’s reaction (about 29 percent), and the child’s fears or nerves around the needle (about 4 percent).
Many patients and parents may find an epinephrine nasal spray more convenient and less frightening to use. Some advisory committee members did raise concerns about the lack of real-world clinical data on nasal epinephrine (due to studies being conducted on healthy volunteers, for ethical and safety reasons) and ARS data showing that “it takes a few minutes longer for nasal epinephrine to reach peak concentration in the blood” compared to EpiPen injection, according to Allergic Living. However, other experts noted that a patient or parent may be more willing to use a nasal spray instead of an EpiPen and may therefore use it more quickly, cutting down on delays and potentially making up for a slower absorption rate.
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The FDA originally set September 19 as a target date to announce its approval of the drug, so we should get more information shortly. If approved, this potentially life-saving nasal spray could be in the hands of parents and patients very soon.
Before you go, check out these cold-relieving products for your child:
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