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How Sturdy Is PK/PD Bridge Between Epinephrine Injection Products And Nasal Spray?

 
• By Brenda Sandburg

FDA enumerates uncertainties in determining whether PK/PD results support a favorable risk-benefit assessment for use of ARS Pharmaceuticals’ epinephrine nasal spray for emergency treatment of allergic reactions, including anaphylaxis.

Bridge
FDA approval of epinephrine nasal spray depends on bridging PK/PD data from injection products • Source: Shutterstock

The US Food and Drug Administration is asking an advisory committee to vote on whether the pharmacokinetic and pharmacodynamic data of ARS Pharmaceuticals, Inc.’s intranasal epinephrine are “sufficiently robust” compared to epinephrine injection products to support a favorable benefit-risk assessment of this novel route of administration.

The agency did not indicate how it comes down on the question in a briefing document prepared for the...

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