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.



Italy Oyster Farmers Dream of Pearls from Warming Mediterranean 

A pearl oyster called Pinctada radiata is shown next to a farming site in the gulf of poets at La Spezia, Italy, August 29, 2024. (Paolo Varrella/Handout via Reuters) 
A pearl oyster called Pinctada radiata is shown next to a farming site in the gulf of poets at La Spezia, Italy, August 29, 2024. (Paolo Varrella/Handout via Reuters) 
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Italy Oyster Farmers Dream of Pearls from Warming Mediterranean 

A pearl oyster called Pinctada radiata is shown next to a farming site in the gulf of poets at La Spezia, Italy, August 29, 2024. (Paolo Varrella/Handout via Reuters) 
A pearl oyster called Pinctada radiata is shown next to a farming site in the gulf of poets at La Spezia, Italy, August 29, 2024. (Paolo Varrella/Handout via Reuters) 

Pearls may soon be cultivated in European seas for the first time ever, as Italian oyster farmers seek to exploit an unexpected opportunity offered by the rapidly warming Mediterranean.

In late 2023, the first specimens of Pinctada radiata, a pearl oyster native to the Red Sea, were spotted in the Gulf of Poets, a popular tourist area around 100 kilometers (62 miles) from Genoa on Italy's north-western coast.

Less than a year later, they are proliferating in what have always been some of the Mediterranean's coldest waters, more normally associated with other types of oyster used for food rather than jewellery.

"We are looking into the possibility of producing cultivated pearls here," said Paolo Varrella, the head of a cooperative that has been breeding food oysters in the area since 2011.

The group has already made contact with pearl oyster farmers in Mexico to get tips on production techniques, Varrella said.

"The Pinctada radiata has been reported in the Ionian Sea around the island of Sicily since the 1970s, but only in the last decade has it moved north" to the cooler Tyrrhenian and Ligurian seas that lap the western Italian mainland, said Salvatore Giacobbe, professor of ecology at the University of Messina.

It is the latest in a succession of alien warm-water species to enter the Mediterranean as it heats up due to climate change.

Manuela Falautano, a scientist at the Italian environmental research and protection institute ISPRA, said this trend had seen "an exponential increase" in the last decade.

Some of these species are aggressive and disrupt delicate ecosystems. In a few cases, such the spotted puffer fish and the scorpion fish, they are also dangerous to humans.

The 2.5 million square kilometer (970,000 square mile) expanse of water that separates southern Europe from Africa and the Middle East is heating up faster than the average of the world's seas, Falautano said.

BIG MONEY

Pearl production, more readily associated with Polynesian atolls than the northern Mediterranean, has an annual global turnover of 11 billion dollars, and Italian oyster farmers are keen to cash in.

Adriano Genisi, a pearl importer for more than 30 years, said the Radiata may produce gems similar to Japan's renowned "Akoya" pearls which have a diameter of 5-9 millimeters and a white color with shades of grey, pink and green.

If all goes well the first pearls could be harvested in about a year, he said.

The rising temperature of the Mediterranean is also blamed for an increase in violent storms such as the one that sank the luxury yacht of British tech entrepreneur Mike Lynch off Sicily last month, killing six passengers and the boat's cook.

Franco Reseghetti, a researcher at Italy's National Institute for Geophysics and Vulcanology, said measurements taken in the Tyrrhenian in December at depths of between 300 and 800 meters showed the highest temperatures since 2013, and he expected to see a further increase this year.

"The huge amount of energy behind this heating can act as a fuel for devastating atmospheric phenomena" such as the violent storm which appeared to have sunk the yacht off Sicily, Reseghetti said.