VIDEO: FDA-requested study of epinephrine nasal spray underway

Key takeaways:

• ARS Pharma’s neffy nasal spray treats anaphylaxis.
• An FDA advisory committee recommended approval.
• The FDA asked for another study involving nasal allergy conditions.

ANAHEIM, Calif. — ARS Pharma is conducting an additional clinical trial of its neffy epinephrine nasal spray per FDA request, company cofounder, president and CEO Richard Lowenthal, MS, MSEL, told Healio.

The spray is designed to treat anaphylaxis and other type 1 allergic reactions as an alternative to epinephrine autoinjectors and other needle deliveries.

“The FDA is asking us to do an additional study where we do twice dosing under nasal allergy challenge conditions,” Lowenthal said at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

The FDA requested this additional study even though its Pulmonary-Allergy Drug Advisory Committee did not believe such a study was necessary and recommended approval, he continued.

“ARS is hopeful that we will be able to finish this study by the middle of the first half of next year,” Lowenthal said.