The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions.
The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said.
The two-milligram spray, called Neffy, is designed to block allergic reactions, including a serious condition called anaphylaxis, which can happen within seconds or minutes of being exposed to an allergen.
The decision introduces an alternative to auto-injector devices such as the EpiPen for blocking severe allergic reactions. It also vindicates the approach of Neffy manufacturer ARS Pharmaceuticals, which pitched its product as a superior way of treating anaphylaxis that overcomes people’s hesitation to inject themselves or someone else. Anaphylaxis can cause constriction of the airways, plummeting blood pressure and a racing pulse.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, FDA’s associate director of the Division of Pulmonology, Allergy and Critical Care, said in a statement.
Richard Lowenthal, CEO of ARS, said in a statement Friday that “this approval marks a watershed moment in addressing an unmet medical need” for people with severe allergies. Neffy, Lowenthal said, “avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many.”
ARS shares surged on the news Friday and were up about 10 percent in midday trading. The company didn’t immediately respond to a request for comment.
The approval comes nearly a year after the FDA surprised ARS by requesting an additional study before making a decision. A panel of outside experts, convened by the FDA, had previously endorsed Neffy, voting 16-6 in favor of approving the drug for adults and 17-5 for children weighing at least 66 pounds.
Still, the committee acknowledged some uncertainty because of a lack of clinical data. While epinephrine has been used for more than a century, it had never before been subjected to the FDA’s exhaustive process to demonstrate safety and effectiveness. ARS, based in San Diego, brought together executives who previously had developed Narcan, the nasal spray used to revive people from opioid overdoses.
An ARS executive once quipped that Neffy would “make the current needle injectors as dated a technology as the flip phone.”
(c) Washington Post