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FDA Greenlights Needle-Free EpiPen Alternative For Anaphylaxis

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Needle-Free EpiPen Alternative

Source: Halfpoint Images / Getty

The first needle-free emergency treatment for potentially fatal allergic reactions has been approved by the Food and Drug Administration (FDA).

It’s a spray called Neffy. It’s being seen as an alternative to the EpiPen and other auto injectors like Kaleo’s Auvi-Q. They are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.

Anaphylaxis is a severe, life-threatening allergic reaction. It can involve multiple parts of the body. Overall, it sends the body in a medical emergency after events like a bee sting or ingesting nuts if someone is allergic. 

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Neffy is sold as a single-dose nasal spray administered into one nostril. If conditions don’t improve, it can be administered again, but in a different nostril by using a different bottle of Neffy. It’s approved for use in adult and young patients who weigh at least 66 pounds.

“Some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, an associate director at the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need.”

Neffy was approved after four studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following the administration of Neffy or other approved epinephrine injection products.

“Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required,” the FDA notes.

The FDA didn’t approve the spray at first. The declined to do it last year because the agency wanted additional testing. That decision went against the recommendation from its independent experts.

Some medical conditions such as a history of nasal surgery could affect how well Neffy absorbs through the tissues in the nose. The FDA said people with a medical history like that should consult a health care provider before using Neffy.

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The post FDA Greenlights Needle-Free EpiPen Alternative For Anaphylaxis appeared first on Elev8.


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