FDA requests additional data on first needle-free antidote for severe allergic reactions.

FDA requests additional data on first needle-free antidote for severe allergic reactions.

Needle-Free Alternative to EpiPen Delayed in FDA Approval Process

In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has decided not to approve a needle-free alternative to the EpiPen for treating severe allergic reactions. The Neffy nasal spray, designed as a user-friendly alternative to the injectable EpiPen, was widely expected to be approved. However, the FDA has requested that additional studies be conducted before granting approval.

The FDA’s decision comes as a disappointment to ARS Pharmaceuticals, the maker of Neffy. Richard Lowenthal, the co-founder, president, and CEO of the company, expressed deep disappointment in the delay, stating that it further hinders access to a potentially life-saving treatment for millions of people at risk of severe allergic reactions. However, he remains committed to completing the requested trial as soon as possible.

Dr. Scott Sicherer, director of the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai in New York City, expressed disappointment with the FDA’s decision, emphasizing the need for more options to treat severe allergic reactions. Both Neffy and EpiPen deliver epinephrine, a medication that relaxes the muscles in the airways. However, Neffy offers the advantage of being a needle-free nasal spray, making it an attractive option for individuals with needle phobia or anxiety about injecting themselves.

During an anaphylactic reaction, symptoms such as trouble breathing, hives, nausea, and vomiting can occur suddenly when a person is exposed to a triggering food, medication, or insect sting. The timely administration of epinephrine can effectively halt this potentially fatal chain of symptoms.

Dr. Payel Gupta, an assistant clinical professor at SUNY Downstate Medical Center in New York City and a volunteer medical spokeswoman for the American Lung Association, believes that having a needle-free option would benefit those who are afraid of needles or injection. However, she also highlights the importance of having epinephrine available in any form. Epinephrine is a lifesaving medication, and every individual with a history of potentially severe allergies should carry it at all times. In fact, experts recommend carrying two EpiPens, as one dose may not be sufficient in some cases.

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Dr. Sicherer echoes this sentiment, emphasizing the urgency of using an epinephrine device at the first sign of an allergic reaction. Waiting for severe symptoms to develop, such as trouble breathing or passing out, can be dangerous. He reassures individuals that epinephrine is a safe and effective medication, and while it may cause a momentary discomfort, its potential life-saving benefits far outweigh any temporary discomfort.

Having access to epinephrine, whether through a traditional EpiPen or a future needle-free alternative like Neffy, is crucial for individuals with severe allergies. It is recommended that anyone experiencing an allergic reaction use their epinephrine device immediately, without hesitation.

Additional Information

For more information on handling severe allergy attacks, consult reliable sources such as healthcare professionals, medical organizations, and educational websites. It is essential to stay informed and proactive in managing allergies to ensure personal safety and to protect against potential life-threatening reactions.

Sources: – Scott Sicherer, MD, director, Elliot and Roslyn Jaffe Food Allergy Institute, division chief, allergy and immunology, Department of Pediatrics; Mount Sinai Health System, New York City – Payel Gupta, MD, assistant clinical professor, SUNY Downstate Medical Center, New York City, volunteer medical spokeswoman, American Lung Association – ARS Pharmaceuticals, news release, Sept. 19, 2023