FDA rejects the initial needle-free EpiPen substitute

The FDA rejected an epinephrine nasal spray that would have been the first needle-free alternative to EpiPens.

In a statement late Tuesday night, ARS Pharmaceuticals said the agency required further study on Neffy to justify approval.

The agency's advisory council recommended medicine approval for children and adults in May, but it was rejected. Rarely does the FDA reject committee-recommended medications.

Epinephrine has been used in the U.S. since 1901 and is successful in reversing anaphylaxis, the most severe allergic reaction. Peanut or cat dander can cause anaphylaxis within minutes. Treatment is necessary to prevent death.

However, all epinephrine treatments must be injected, which might be difficult for needle-phobic patients.

At the May advisory committee meeting, a paucity of clinical evidence, notably on anaphylaxis, was a serious issue.

Based on animal and non-anaphylaxis investigations, ARS Pharmaceuticals reported the nasal spray was "comparable" to an EpiPen.

Despite its misgivings, the panel voted 16-6 for adult usage and 17-5 for kid use.

The FDA wants a study comparing Neffy to an epinephrine autoinjector for allergen-induced sneezing, itching, and congestion.

Drugmaker expects to resubmit FDA application in first half of 2024.