The FDA decided not to approve the first needle-free alternative to an EpiPen and asked for more research to be conducted.
The decision came as a surprise to many because the FDA’s advisory committee voted in favor of the “neffy” device back in May. The device is a nasal spray that would be used to treat severe allergic reactions.
Research has shown that epinephrine at a higher dose can be absorbed into the blood at similar levels as an injection. The nasal spray device is already being used to administer other drugs, including naloxone, and is easy to use.
When the neffy epinephrine nasal spray was reviewed back in May by an FDA committee, there was concern that the product had not been tested in patients having actual anaphylactic reactions -- because doing a study like that would be extremely difficult.
Instead, the manufacturer did studies showing their device produced blood epinephrine levels that were equivalent to injected epinephrine -- but that isn’t why the FDA declined to approve the device.
In a press release, ARS Pharmaceuticals says, “the FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval. 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 FDA wants a study comparing two doses of the nasal spray to two injections when a person has a stuffy nose triggered by allergies. ARS Pharmaceuticals argues their product could be lifesaving for the millions at risk of a severe allergic reaction who don’t have an EpiPen or other injector -- and those who don’t consistently carry them.
The company said it is disappointed and plans to appear the FDA’s decision.