The Food and Drug Administration approved the first needle-free alternative to the EpiPen on Friday, a single-use epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis.
The agency said it approved Neffy, from ARS Pharmaceuticals, for use in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).
In a surprise move last year, FDA declined to approve Neffy despite a favorable recommendation from an advisory committee. Instead, the agency asked the manufacturer to complete a study comparing repeat doses of Neffy to repeat doses of epinephrine injection.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, associate director of FDA’s Division of Pulmonology, Allergy and Critical Care, said in a statement. “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.”
Epinephrine has been used since 1901 and is the first line of defense to treat allergic reactions. But all current epinephrine treatments, like the well-known EpiPen and other autoinjectors, use needles — which poses a problem if people are needle-phobic.
The approval represents the first significant change in epinephrine delivery in more than 35 years, the company said.
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies — a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” Richard Lowenthal, ARS co-founder, president and CEO said in a statement.
Neffy is a single dose nasal spray administered into one nostril. A second dose (using a new nasal spray in the same nostril) may be given if there is no improvement in symptoms or if symptoms worsen.
The company said Neffy is expected to be available within eight weeks of FDA approval.
Aside from being needle-free, part of the appeal of the device is that it could provide competition to the expensive EpiPen.
In 2007, a pack of two injectors cost $100, but when Mylan bought the product, it hiked the cash price to more than $600 by 2016 — despite each pen costing a fraction of that to make.
As a result of the outcry, Mylan began selling an “authorized generic” for $300. An authorized generic is essentially the same product as the brand-name drug, just marketed without the brand name.
For people with severe allergic reactions who have commercial insurance that covers Neffy, ARS said it will use a copay savings program to limit the cost to $25 for each filled prescription of two single-use Neffy devices.
For eligible patients without insurance coverage, or in situations where a health plan does not yet cover the product, or if a patient faces high out-of-pocket costs due to a high-deductible plan, ARS said it will offer a cash price of $199 for two doses of Neffy through digital pharmacy BlinkRx.
The cash price is also available for patients who use GoodRx at retail pharmacies, the company said.