A nasal spray alternative to shots for people with super-serious allergic reactions may soon be available in the U.S.
The U.S. Food and Drug Administration has approved ARS Pharma’s “neffy” — marketed without a capital letter — for adults and children who weigh at least 66 pounds and have a type of dangerous allergic reaction called anaphylaxis. Typically, those have required a shot of epinephrine.
The product should be available within eight weeks, the company said.
Severe allergies can be related to foods, medicines and insect stings. Symptoms of anaphylaxis include a hard time breathing or swallowing, hives, swelling, cramps, nausea, fast pulse and a drop in blood pressure. Anaphylaxis can be deadly. Medscape reported that as many as 2% of people in the U.S. — almost 7 million people — have “a lifetime chance of having anaphylaxis.”
How neffy works
ARS Pharma said in a news release that “neffy offers adults and children living with severe allergic reactions the first new delivery method for epinephrine in more than 35 years.” The company highlighted the need for an epinephrine delivery method that doesn’t include injection, since many people are reluctant to give someone a shot and treatment is sometimes delayed or not given, which can lead to terrible, even lethal, results.
The company’s announcement included a statement from Dr. Thomas B. Casale, professor of medicine and pediatrics and chief of Clinical and Translational Research University of South Florida’s Division of Allergy and Immunology: “FDA approval of neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.”
Medscape reported that “neffy is taken as a single dose sprayed into one nostril, and a combination of four studies among 175 healthy adults showed the product could achieve a blood epinephrine level similar to what you’d get from a shot, as well as a similar increase in blood pressure and heart rate. In a study of children weighing more than 66 pounds, blood concentration levels after taking neffy were similar to levels seen in adults who used the product.”
According to the article, “People with some nasal conditions or a history of nasal surgery should talk to a health care professional about whether they should use neffy, the FDA advised, and the product also may not be safe for some people with certain other conditions or sulfite allergies.”
ARS Pharma noted that about a half-million emergency room visits each year are the result of a life-threatening allergic reaction. Most of the time, an epinephrine shot has not been given before arriving at the hospital.
What will neffy cost?
The company said that it “plans to offer robust programs to support patient access” and will limit what most people with insurance that covers neffy pay to $25 for a two-use prescription. “For eligible patients without insurance coverage, situations in which a health plan does not yet cover neffy, or if a patient faces high out-of-pocket costs due to a high-deductible plan, ARS Pharma will offer a cash price of $199 for two doses of neffy via BlinkRx, a digital pharmacy service that is available to patients at no added cost.”
That price is also available to those who use retail pharmacies through GoodRx or whose insurance plans will not cover neffy. For patients who have no insurance or inadequate insurance and “meet certain eligibility criteria and have exhausted all other options,” it has a patient assistance program that will provide neffy at no cost, the announcement said.