The FDA has rejected approval for a nasal spray alternative to epinephrine autoinjectors like EpiPens, citing the need for further study.
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ARS Pharma, the maker of the nasal spray called "neffy," has been asked to conduct a study comparing the impact of repeat doses of neffy to epinephrine injection.
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The FDA Advisory Committee had recommended neffy's approval in May 2023 without the need for additional study.
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Around 32 million people in the U.S. suffer from food allergies, and anaphylaxis may lead to up to 200 deaths annually.
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Neffy is designed for easy carrying and administration, offering a needle-free epinephrine treatment.
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The device works similar to Narcan, a nasal spray used for reversing opioid overdoses, requiring no preparation or activation.
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Neffy's mechanism allows epinephrine to be absorbed automatically by the nasal mucosa, making it effective even if the person isn't breathing or doesn't snort the medication.
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Data presented to the FDA indicates that neffy performs similarly to injected epinephrine, with comparable variability.
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Reported side effects of neffy include mild nasal discomfort, headache, runny nose, nausea, dizziness, vomiting, and mild throat irritation.
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The nasal spray's user-friendly design means it could be more widely available in settings like schools, airplanes, and first-aid kits, without the need for specific training.
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