FDA Issues Some Concerns Regarding ARS Pharma's Investigational Allergy Treatment

The FDA released briefing documents ahead of the advisory committee for ARS Pharmaceuticals Inc's SPRY neffy (ARS-1) for the emergency treatment of allergic reactions (type I), including anaphylaxis in adults and children,

The meeting is scheduled for Thursday, May 11.

Neffy is an intranasal epinephrine product.

Some of the key issues outlined in the briefing documents include:

The briefing documents note that epinephrine injection has been used since before 1938, and its effectiveness has never been evaluated.

As such, there is a paucity of data for epinephrine injection products, and the PK endpoints critical to establishing efficacy have not been determined. There is limited data on the ideal safe and effective dose beyond a generally accepted level of 0.01 mg/kg.

The briefing documents cite substantial variability in the PK profiles of epinephrine injection products used as comparators in the clinical studies of ARS-1 despite being administered by the same route, raising questions about which of the approved products should be used as the comparator and which PK endpoints are the most critical to ensure efficacy.

The FDA staff notes that topical administration of epinephrine causes constriction of local blood vessels, which could potentially change the absorption of epinephrine in the nasal mucosa and impact systemic plasma concentrations.

Price Action: SPRY shares are down 14.39% at $5.14 on the last check Tuesday.