FDA Rejects The Initial Needle-Free Epipen Substitute And Requests Additional Study
The FDA declined to approve the first needle-free EpiPen substitute and requested additional research instead. Since the FDA advisory group decided in favour of the “neffy” device back in May, the decision surprised many people. A nasal spray would be used to administer the medication to treat severe allergic responses. A larger dose of epinephrine can be absorbed into the blood at levels comparable to an injection, according to research. Naloxone is already administered via the simple-to-use nasal spray device, along with other medications. There was worry that the neffy epinephrine nasal spray had not been tested on patients who had really experienced anaphylactic responses when it was being assessed back in May by an FDA committee since conducting a trial like that would be very challenging. Instead, the firm conducted trials indicating that their product produced blood levels of epinephrine that were comparable to injections, but this is not the reason the FDA rejected the de...