FDA Panel Takes ‘Leap Of Faith’ In Backing Epinephrine Nasal Spray For Anaphylaxis

 
• By Brenda Sandburg
  
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In a split vote, advisory committee finds PK/PD data support favorable benefit-risk assessment of ARS Pharmaceuticals’ neffy, but calls for postmarket studies to evaluate its clinical efficacy.

epinephrine
FDA advisory panel finds PK/PD data supports favorable assessment of intranasal epinephrine for treatment of anaphylaxis • Source: Shutterstock

The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee was divided over whether pharmacokinetic and pharmacodynamic data on ARS Pharmaceuticals, Inc.’s intranasal epinephrine is sufficient to support use of the drug for treatment of Type I allergic reactions, including anaphylaxis. While a majority concluded that it was, others said clinical data is needed to show that it is effective.

At its 11 May meeting, the panel voted 16-6 that the PK/PD results support a favorable benefit-risk assessment for the...

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