FDA Approves First Nasal Spray to Treat Dangerous Allergic Reactions

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
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FDA Approves First Nasal Spray to Treat Dangerous Allergic Reactions

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights

US health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.

The Food and Drug Administration said it approved the spray from drugmaker ARS Pharmaceuticals Inc. as an emergency treatment for adults and older children experiencing life-threatening allergic reactions known as anaphylaxis, The AP reported.

Anaphylaxis occurs when the body's immune system develops a sudden, unexpected reaction to a foreign substance, such as food, insect stings or medications. Common symptoms include hives, swelling, itching, vomiting and difficulty breathing.

The device, marketed as Neffy, could upend treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers. Anaphylaxis sends more than 30,000 people to emergency rooms and results in more than 2,000 hospitalizations and more than 230 deaths in the US each year.

Of the 6 million prescriptions written for auto-injectors each year, more than 40% are never filled, Dr. Thomas Casale, an allergist at the University of South Florida, told an FDA advisory panel last year. Even when they are available to caregivers, many auto-injectors are used incorrectly, he said.

“There’s a real unmet medical need for a large portion of the population,” he said.

Neffy is intended for people who weigh at least 66 pounds. It is given in a single dose sprayed into one nostril. A second dose can be given if the person’s symptoms don’t improve.

The new treatment could be life-changing for people with severe food allergies, said Dr. Kelly Cleary, a pediatrician and director with the Food Allergy Research & Education, a nonprofit advocacy group.

“I have seen the look of worry or fear,” said Cleary, whose 11-year-old son has multiple food allergies. “I worry about what happens if someone hesitates.”

Requiring an injection in an emergency is as scary to some children as the allergic reaction itself. Some parents have had to restrain thrashing children to inject them, sometimes causing cuts that require stitches. About 3,500 caregivers a year are injured when they accidentally inject themselves in the hands, ARS said.

Priscilla Hernandez, of Pasadena, California said her 12-year-old son, Zacky, who is allergic to sesame, peanuts, tree nuts, avocado and other foods, was traumatized when he had a reaction at school about six years ago and a nurse treated him with an auto-injector.

“Having to do a shot creates this whole different level of anxiety,” she said.

She said, “we are over the moon” about the FDA's approval of the spray, which Zacky will start carrying when it becomes available.

First marketed in 1901, epinephrine predates the FDA itself. Products like the EpiPen auto-injector, approved in 1987, were authorized based on chemistry and manufacturing data and were not required to prove safety and efficacy.

Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, ARS officials compared the effect of the nasal spray on biological markers to existing epinephrine treatments.

Results showed Neffy worked about as well as injected epinephrine to boost heart rate and blood pressure, which counter severe reactions. The drug is combined with a patented agent that allows it to be easily absorbed through nasal membranes.



Nearly 250 Million Children Missed School Last Year Because of Extreme Weather, UNICEF Says 

Two maintenance workers clean the tables of one of the classrooms of Zakia Madi middle school, five days before the students return to school, in the village of Dembeni, on the French Indian Ocean territory of Mayotte, on January 22, 2025. (AFP)
Two maintenance workers clean the tables of one of the classrooms of Zakia Madi middle school, five days before the students return to school, in the village of Dembeni, on the French Indian Ocean territory of Mayotte, on January 22, 2025. (AFP)
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Nearly 250 Million Children Missed School Last Year Because of Extreme Weather, UNICEF Says 

Two maintenance workers clean the tables of one of the classrooms of Zakia Madi middle school, five days before the students return to school, in the village of Dembeni, on the French Indian Ocean territory of Mayotte, on January 22, 2025. (AFP)
Two maintenance workers clean the tables of one of the classrooms of Zakia Madi middle school, five days before the students return to school, in the village of Dembeni, on the French Indian Ocean territory of Mayotte, on January 22, 2025. (AFP)

At least 242 million children in 85 countries had their schooling interrupted last year because of heatwaves, cyclones, flooding and other extreme weather, the United Nations Children's Fund said in a new report Friday.

UNICEF said it amounted to one in seven school-going children across the world being kept out of class at some point in 2024 because of climate hazards.

The report also outlined how some countries saw hundreds of their schools destroyed by weather, with low-income nations in Asia and sub-Saharan Africa hit especially hard.

But other regions weren't spared the extreme weather, as torrential rains and floods in Italy near the end of the year disrupted school for more than 900,000 children. Thousands had their classes halted after catastrophic flooding in Spain.

While southern Europe dealt with deadly floods and Asia and Africa had flooding and cyclones, heatwaves were “the predominant climate hazard shuttering schools last year,” UNICEF said, as the earth recorded its hottest year ever.

More than 118 million children had their schooling interrupted in April alone, UNICEF said, as large parts of the Middle East and Asia, from Gaza in the west to the Philippines in the southeast, experienced a sizzling weekslong heatwave with temperatures soaring above 40 degrees Celsius (104 Fahrenheit).

“Children are more vulnerable to the impacts of weather-related crises, including stronger and more frequent heatwaves, storms, droughts and flooding,” UNICEF executive director Catherine Russell said in a statement. “Children’s bodies are uniquely vulnerable. They heat up faster, they sweat less efficiently, and cool down more slowly than adults. Children cannot concentrate in classrooms that offer no respite from sweltering heat, and they cannot get to school if the path is flooded, or if schools are washed away."

Around 74% of the children affected in 2024 were in middle- and low-income countries, showing how climatic extremes continue to have a devastating impact in the poorest countries. Flooding ruined more than 400 schools in Pakistan in April. Afghanistan had heatwaves followed by severe flooding that destroyed over 110 schools in May, UNICEF said.

Months of drought in southern Africa exacerbated by the El Niño weather phenomenon threatened the schooling and futures of millions of children.

And the crises showed little sign of abating. The poor French territory of Mayotte in the Indian Ocean off Africa was left in ruins by Cyclone Chido in December and hit again by Tropical Storm Dikeledi this month, leaving children across the islands out of school for six weeks.

Cyclone Chido also destroyed more than 330 schools and three regional education departments in Mozambique on the African mainland, where access to education is already a deep problem.

UNICEF said the world's schools and education systems “are largely ill-equipped” to deal with the effects of extreme weather.