On Tuesday, Sept. 19, the Food and Drug Administration decline to approve Neffy, a nasal spray equivalent of an EpiPen. The first needle-free option to treat severe allergic reactions made by ARS Pharmaceuticals was declined approval as the FDA requested more testing on repeat doses.
The decision by the FDA was surprising for the drug developer ARS. According to an ARS statement, in a May 2023 meeting, the FDA’s Pulmonary-Allergy Drugs Advisory Committee concluded the benefits of Neffy outweigh the risks.
“In that session, no member of the Committee raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose Neffy, which showed enhanced absorption during the time period when a clinical response would be expected,” the statement read.
The May 2023 conclusion came with a PADAC vote backing the use of the needle-injected epinephrine alternative in adults and children weighing at least 66 pounds.
The FDA wants a repeat-dose study on the nasal spray to compare results to an epinephrine injection before the drug can be approved. This is a requirement that ARS said had already been discussed.
“This request comes after the recommendation of the FDA Advisory Committee (PADAC) in May 2023 to approve Neffy without the need for additional studies to demonstrate its efficacy or safety,” the statement read.
ARS added a less expensive needle-free alternative is needed now more than ever as the cost of emergency allergy injectors increases. One study shows that two-thirds of patients pay $200 annually for emergency allergy injections.
ARS plans on resubmitting Neffy for FDA approval in 2024 and anticipates action in the second half of 2024.
