FDA declines to approve neffy, a needle-free EpiPen alternative

Neffy would work as a needle-free alternative to epinephrine autoinjectors
FDA: Neffy needs further research
ARS CEO: "We are very surprised by this action"

Updated: Sep 21, 2023 / 04:56 AM CDT

An epinephrine shot and antihistamine are seen are seen in an observation area as the Pfizer COVID-19 vaccine is administered to staff at the Goodwin House Bailey’s Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020. (Photo by Brendan Smialowski / AFP) (Photo by BRENDAN SMIALOWSKI/AFP via Getty Images)

This story has been updated to clarify the drug application’s status.

CHICAGO (NewsNation) — The Food and Drug Administration did not approve a new nasal spray for allergic reactions, requesting further studies and review of the proposed treatment before a final decision.

ARS Pharmaceuticals, Inc.’s experimental drug, neffy, would work as a needle-free alternative to epinephrine autoinjectors, including EpiPens. Neffy would be used as a nasal spray for those suffering from several allergic reactions, including anaphylaxis for adults and children.

The decision came as a shock, since the FDA Advisory Committee (PADAC) recommended the approval of the epinephrine nasal spray without further research back in May 2023.

“We are very surprised by this action,” CEO of ARS Pharmaceuticals Richard Lowenthal said in the statement.

Plus, the FDA and ARS Pharma previously agreed on final labeling and marketing back in August 2023, according to the press release.

The statement by the FDA released Tuesday said that ARS Pharmaceuticals needed to conduct further studies on consecutive use of the drug.

The Asthma and Allergy Foundation of America (AAFA) told NewsNation in a statement that it was disappointed neffy did not receive FDA approval but understands that the agency has requested additional data.

“People at risk of anaphylaxis deserve to have a choice in treatment,” the statement read in part.

ARS Pharmaceuticals said it plans on appealing the FDA’s request for further research.