FDA re­jects first nasal spray al­ter­na­tive to EpiPen for those with se­vere al­ler­gies

ARS Phar­ma­ceu­ti­cals re­vealed late Tues­day evening that the FDA re­ject­ed what would have been the first ep­i­neph­rine nasal spray.

The FDA re­quest­ed an­oth­er phar­ma­co­ki­net­ic/phar­ma­co­dy­nam­ic study as­sess­ing re­peat dos­es of the nasal spray, which would have been known as neffy, com­pared to re­peat dos­es of an ep­i­neph­rine in­jec­tion un­der al­ler­gen-in­duced al­ler­gic rhini­tis con­di­tions to sup­port ap­proval. ARS said it will file a for­mal dis­pute with FDA, which is usu­al­ly a last-ditch ef­fort to sway the agency.

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