ARS Pharmaceuticals Gets FDA Committee Meeting for Neffy

By Chris Wack

ARS Pharmaceuticals Inc. said Tuesday that the U.S. Food and Drug Administration has scheduled a Division of Pulmonology, Allergy and Critical Care Advisory Committee meeting on May 11 to review its new drug application for neffy.

The company said neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions, including anaphylaxis.

The FDA told ARS Pharma that additional experts with knowledge in systemic allergic reactions and anaphylaxis will be invited to participate in the Advisory Committee.

The company's NDA submission for neffy was accepted for review by the FDA with a Prescription Drug User Fee Act target action date anticipated in mid-2023.

ARS Pharma shares closed Monday's session down 12%, but are up 82% in the past 12 months.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

03-28-23 1004ET