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