ARS Pharmaceuticals Notches Win with FDA Adcomm Vote Recommending EpiPen Alternative
May 12, 2023
ARS Pharmaceuticals scored a win yesterday, May 11th, with a 16-6 Food and Drug Administration (FDA) advisory committee vote recommending the approval of its epinephrine nasal spray. Not only would this be the first nasal spray of the drug, but it would also represent a major challenger to Epipen’s dominance in the market.
According to Zachary Brennan, “The vote was a surprise as multiple adcomm members questioned the nasal spray’s benefit-risk profile, and called for some clinical data on the nasal spray to be produced before it can be approved, although some questioned whether a smaller clinical study might be enough.”
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(Source: Endpoints, May 11th, 2023)