The FDA released Information documents before the Advisory Board for ARS Pharmaceuticals Inc WARM neffy (ARS-1) for emergency treatment of allergic reactions (type I), including anaphylaxis in adults and children,

The meeting is scheduled for Thursday, November 11th.

Neffy is an intranasal epinephrine product.

Some of the key issues sketched The briefing documents include:

The briefing documents note that epinephrine injections have been used since before 1938 and their effectiveness has never been evaluated.

As a result, data for epinephrine injection products are scarce and the PK endpoints critical to determining efficacy have not been determined. There is limited data on the ideal safe and effective dose above a generally accepted level of 0.01 mg/kg.

The briefing documents indicate significant differences in the PK profiles of epinephrine injection products used as comparators in the clinical trials of ARS-1, despite being administered by the same route, raising the question of which of the approved products as comparator and which PK should be used Endpoints are the most critical to ensure efficacy.

FDA staff note that topical administration of epinephrine causes local blood vessel constriction, which could potentially alter the absorption of epinephrine in the nasal mucosa and affect systemic plasma concentrations.

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