Skip to main content

FDA says it needs more research before deciding to approve nasal spray to treat dangerous allergies

A sign for the U.S. Food and Drug Administration is displayed outside their offices, Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta, File) A sign for the U.S. Food and Drug Administration is displayed outside their offices, Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta, File)

Federal regulators declined to approve a nasal spray to treat severe allergic reactions late Tuesday, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.

The U.S. Food and Drug Administration told ARS Pharmaceuticals Inc., of San Diego, that the company needs to conduct another study on repeat doses of epinephrine, a drug that halts potentially life-threating reactions, called anaphylaxis, using the company's nasal spray device compared with injections.

The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. The FDA is not required to follow the committee's recommendations, though it usually does.

Richard Lowenthal, president and chief executive of ARS, said in a statement that the company would appeal the FDA's decision and resubmit an application in early 2024.

The ARS product is one of several needle-free devices being developed to treat dangerous reactions to food, insect stings and medications. Such a device could alter treatment for the between 33 million and 45 million Americans with severe allergies to food and other triggers.

Advocates for people with allergies said they were “frustrated” by the FDA's request for more research.

“Our community believe this innovation would finally come to the more than 10 per cent of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer,” Sung Poblete, chief executive of Food Allergy Research & Education, a nonprofit group, said in a statement. Top Stories

Ontario doctors disciplined over Israel-Gaza protests

A number of doctors are facing scrutiny for publicizing their opinions on the Israel-Hamas war. Critics say expressing their political views could impact patient care, while others say that it is being used as an excuse for censorship.

'No concessions' St-Onge says in $100M a year news deal with Google

The Canadian government has reached a deal with Google over the Online News Act that will see the tech giant pay $100 million annually to publishers, and continue to allow access to Canadian news content on its platform. This comes after Google had threatened to block news on its platform when the contentious new rules come into effect next month.

Live updates

Live updates Hamas frees 10 Israeli women and children, 4 Thai nationals

Ten Israeli women and children and four Thai nationals held captive in Gaza were freed by Hamas, and Israel followed with the release of a group of Palestinian prisoners Thursday. It was the latest exchange of hostages for prisoners under a temporary cease-fire in the Gaza war. Two Russian-Israeli women were also freed by Hamas in a separate release.


opinion Don Martin: With Trudeau resignation fever rising, a Conservative nightmare appears

With speculation rising that Prime Minister Justin Trudeau will follow his father's footsteps in the snow to a pre-election resignation, political columnist Don Martin focuses on one Liberal cabinet minister who's emerging as leadership material -- and who stands out as a fresh-faced contrast to the often 'angry and abrasive' leader of the Conservatives.

Stay Connected