In Surprise Move, FDA Rejects Needle-Free EpiPen Rival

It wants ARS Pharmaceuticals to conduct additional research on its Neffy nasal spray
By Kate Seamons,  Newser Staff
Posted Sep 20, 2023 9:13 AM CDT
In Surprise Move, FDA Rejects Needle-Free EpiPen Rival
   (Getty Images / CarrieCaptured)

In a surprise move, the FDA declined to grant approval to a nasal spray that would be the first needle-free alternative to epinephrine autoinjectors—more commonly referred to by the brand name EpiPen. In May, the FDA's advisory committee voted to recommend approval of ARS Pharmaceuticals' Neffy. But in a statement issued late Tuesday, the agency said the company needed do further study on the drug and provide additional data. NBC News calls it "rare" for the FDA to not grant approval to drugs that have gotten the green light from its committees. Indeed, ARS Pharmaceuticals CEO Richard Lowenthal said the company is "very surprised by this action."

Reuters reports the FDA wants to see data from a repeat-dose study involving Neffy and a rival injected product before a potential approval rather than after, as the two sides had earlier agreed upon. In June, EpiPen-maker Viatris had petitioned the FDA to require that ARS conduct additional trials "that closely mimic real-world conditions," per Reuters. NBC News adds that the committee hadn't been unanimous in recommending the drug, with some having qualms over the absence of clinical data involving testing on people experiencing anaphylaxis, the most extreme form of allergic reaction.

Without treatment, anaphylaxis can lead to death, and the only available epinephrine treatments are injectable and therefore involve needles. ARS Pharmaceuticals had studied Neffy in animals and in people without anaphylaxis, and CBS News says the company's surveys found up to 85% of people with severe allergies would be willing to carry a Neffy-like nasal product with them daily, while only 55% were willing to keep an injectable pen on them. Lowenthal says "we aim to complete the newly requested trial as quickly as possible to meet the needs of patients." Reuters says the likely timeline would have ARS resubmitting its application in the first half of 2024, with an FDA decision coming in the latter half of that year. (More epinephrine stories.)

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