FDA Rejects The Initial Needle-Free Epipen Substitute And Requests Additional Study

FDA Rejects The Initial Needle-Free Epipen Substitute And Requests Additional Study | The Lifesciences Magazine

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 device.

FDA rejects needle-free alternative to EpiPen

The FDA requested completion of a pharmacokinetic/pharmacodynamic study comparing repeat doses of neffy to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis circumstances to support approval, according to a press release from ARS Pharmaceuticals. This request follows the FDA Advisory Committee’s (PADAC) May 2023 recommendation that neffy be approved without further proof of its efficacy or safety.

When a person has a stuffy nose brought on by allergies, the FDA wants a study comparing two doses of the nasal spray to two injections. According to ARS Pharmaceuticals, their invention could save the lives of millions of people who are at risk of dying from a severe allergic reaction but do not regularly carry an EpiPen or other injector. The business expressed its disappointment and stated that it will appeal the FDA’s ruling.

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