The U.S. Food and Drug Administration on Friday approved the first needle-free alternative to EpiPen, a disposable epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis.
The agency said it approved ARS Pharmaceuticals’ Nefi for use in adult and pediatric patients weighing 30 kilograms (about 66 pounds) or more.
Last year, the FDA surprisingly declined to approve Nephi, despite a favorable recommendation from an advisory committee. Instead, the FDA asked the manufacturer to complete a study comparing repeated doses of Nephi with repeated doses of epinephrine injections.
“Anaphylaxis can be life-threatening, and people, especially children, may delay or avoid treatment due to fear of injections,” Kelly Stone, M.D., deputy director of the FDA’s division of respiratory, allergy and critical care medicines, said in a statement. “The availability of an epinephrine nasal spray may reduce a barrier to prompt treatment of anaphylaxis. As a result, Nephi provides an important treatment option and addresses an unmet need.”
Epinephrine has been around since 1901 and is the first line of defense for treating allergic reactions. But all current epinephrine treatments, including the well-known EpiPen and other autoinjectors, use needles, which can be problematic for people with needle phobia.
According to the company, this approval marks the first major change in epinephrine dosing in more than 35 years.
“This approval marks a landmark moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the anxiety and fear of receiving epinephrine via needle, which for many is an unsettling and frightening experience,” ARS co-founder, president and CEO Richard Lowenthal said in a statement.
Neffy is a single-dose nasal spray that is administered into one nostril. A second dose (using a new nasal spray in the same nostril) may be given if symptoms do not improve or if symptoms worsen.
The company says Nefi is expected to be available within eight weeks of FDA approval.
Besides being needle-free, one of the device’s attractions is that it rivals the costly EpiPen.
In 2007, a pack of two syringes cost $100, but after Mylan acquired the product, it raised the cash price to more than $600 by 2016, even though each syringe costs a fraction of that amount to manufacture.
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, except that it is sold without the brand name.
ARS said that for people with severe allergic reactions who have private insurance that covers Nephi, a copay savings program will cap the cost per prescription for two disposable Nephi devices at $25.
ARS announced that it will offer two doses of Neffy for the cash price of $199 through its digital pharmacy, BlinkRx, to eligible patients who are uninsured, whose health insurance does not yet cover the product, or who have high deductible plans that would result in high out-of-pocket costs.
The cash price also applies to patients who use GoodRx at retail pharmacies, according to the company.
