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On Sept. 19, the Food and Drug Administration (FDA) requested another study on neffy®, a epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction. This will delay approval of neffy by at least a year.

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted on May 11 to recommend the approval of neffy for both adults and children over age 6. On Sept. 19, the FDA delayed approval and asked for a study on neffy in people with allergic rhinitis.

AAFA’s Statement Regarding the FDA Decision on Needle-Free Epinephrine Nasal Spray

The Asthma and Allergy Foundation of America (AAFA) is disappointed that the epinephrine nasal spray known as neffy did not receive FDA approval but understands the agency is requesting additional data.

Currently, epinephrine is only available in devices that use needles. A nasal spray would give people managing severe allergic reactions (anaphylaxis) more options. And as AAFA told the FDA earlier this year, people at risk of anaphylaxis deserve to have a choice in treatment. In an AAFA study on food allergies in 2019, nearly three out of four people reported not using or receiving a dose of epinephrine during a recent severe allergic reaction. Fear of epinephrine and needle phobia are significant reasons why people are hesitant or delay treatment for a condition that requires immediate action.

Drug safety and efficacy are important to patients and caregivers. Epinephrine itself has a long-proven safety record. The FDA has requested an additional study on epinephrine nasal spray use by people with allergic rhinitis — which could further delay this product from getting approval by at least a year.

We hope needle-free epinephrine drug manufacturers and the FDA are able to find solutions to bring needle-free options to the market sooner rather than later. However, AAFA encourages support for the scientific process for drug development and urges participation in future clinical trials.

If you or your child is at risk for anaphylaxis and has a fear of needles, there are ways you can become more comfortable with injecting epinephrine.

Practice using your epinephrine auto-injector trainer to help you and your child become more comfortable with the process. This will help you understand how the auto-injector works. Follow the instructions for your device and push the trainer against your thigh. After you hear a click, hold the device for a few seconds (you only need hold most devices for two or three seconds). If you have expired epinephrine injectors, you can practice using them on an orange or a grapefruit.

Each epinephrine device may have different steps for use. See Kids with Food Allergies' (KFA) resources on current epinephrine devices, including training videos and patient assistance programs.

Remember that for many auto-injectors, you won’t see the needle at all. After you press the device on your thigh, a needle will release. Once you remove the device, that needle will likely retract back into the device.

Ask your doctor for an Anaphylaxis Action Plan. This will outline how to recognize symptoms of anaphylaxis and help you feel more confident about when to use your epinephrine.

Talk with your doctor about any concerns you have about using epinephrine. Epinephrine is safe and effective. Your doctor can answer your questions and address any concerns you have about using it.

KFA is the food allergy division of AAFA.

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