FDA approves first nasal spray to treat dangerous allergic reactions

TECH

FDA approves first nasal spray to treat dangerous allergic reactions

2024-08-12 06:15 Last Updated At：06:20

U.S. 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.

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 U.S. 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.

Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, of North Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film that is administered under the tongue from Aquestive Therapeutics, of New Jersey.

Neffy is designed to be easy to carry and easy to use, especially for children, said Richard Lowenthal, president and chief executive of San Diego-based ARS.

“We don’t want fear. There’s no needle, there’s no pain with this product,” he said. “It’s basically like spraying saline into your nose.”

ARS didn’t immediately disclose a list price, but said it would make the spray available through certain discount programs for about $200 per two-pack. Insurance plans must still decide whether to cover the product and at what price.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

A shy penguin wins New Zealand's bird election after a campaign filled with memes and tattoos

2024-09-16 17:03 Last Updated At：17:10

WELLINGTON, New Zealand (AP) — It's noisy, smelly, shy — and New Zealand’s bird of the year.

The hoiho, or yellow-eyed penguin, won the country’s fiercely fought avian election on Monday, offering hope to supporters of the endangered bird that recognition from its victory might prompt a revival of the species.

It followed a campaign for the annual Bird of the Year vote that was without the foreign interference scandals and cheating controversies of past polls. Instead, campaigners in the long-running contest sought votes in the usual ways — launching meme wars, seeking celebrity endorsements and even getting tattoos to prove their loyalty.

More than 50,000 people voted in the poll, 300,000 fewer than last year, when British late night host John Oliver drove a humorous campaign for the pūteketeke -- a “deeply weird bird” which eats and vomits its own feathers – securing a landslide win.

This year, the number of votes cast represented 1% of the population of New Zealand — a country where nature is never far away and where a love of native birds is instilled in citizens from childhood.

“Birds are our heart and soul,” said Emma Rawson, who campaigned for the fourth-placed ruru, a small brown owl with a melancholic call. New Zealand's only native mammals are bats and marine species, putting the spotlight on its birds, which are beloved — and often rare.

This year's victor, the hoiho — its name means “noise shouter” in the Māori language — is a shy bird thought to be the world's rarest penguin. Only found on New Zealand's South and Chatham islands — and on subantarctic islands south of the country — numbers have dropped perilously by 78% in the past 15 years.

“This spotlight couldn’t have come at a better time. This iconic penguin is disappearing from mainland Aotearoa before our eyes,” Nicola Toki, chief executive of Forest & Bird — the organization that runs the poll — said in a press release, using the Māori name for New Zealand. Despite intensive conservation efforts on land, she said, the birds drown in nets and sea and can't find enough food.

“The campaign has raised awareness, but what we really hope is that it brings tangible support,” said Charlie Buchan, campaign manager for the hoiho. But while the bird is struggling, it attracted a star billing in the poll: celebrity endorsements flew in from English zoologist Jane Goodall, host of the Amazing Race Phil Keoghan, and two former New Zealand prime ministers.

Aspiring bird campaign managers — this year ranging from power companies to high school students — submit applications to Forest & Bird for the posts. The hoiho bid was run by a collective of wildlife groups, a museum, a brewery and a rugby team in the city of Dunedin, where the bird is found on mainland New Zealand, making it the highest-powered campaign of the 2024 vote.

“I do feel like we were the scrappy underdog,” said Emily Bull, a spokesperson for the runner-up campaign, for the karure — a small, “goth” black robin only found on New Zealand’s Chatham Island.

The karure's bid was directed by the students’ association at Victoria University of Wellington, prompting a fierce skirmish on the college campus when the student magazine staged an opposing campaign for the kororā, or little blue penguin.

The rivalry provoked a meme war and students in bird costumes. Several people got tattoos. When the magazine’s campaign secured endorsements of the city council and local zoo, Bull despaired for the black robin's bid.

But the karure — which has performed a real-life comeback since the 1980s, with conservation efforts increasing the species from five birds to 250 — took second place overall.

This weekend as Rawson wrapped up her campaign for the ruru, she took her efforts directly to the people, courting votes at a local dog park. The veteran campaign manager who has directed the bids for other birds in past years was rewarded by the ruru placing fourth in the poll, her best ever result.

“I have not been in human political campaigning before,” said Rawson, who is drawn to the competition because of the funds and awareness it generates. The campaign struck a more sedate tone this year, she added.

“There’s been no international interference, even though that was actually a lot of fun,” she said, referring to Oliver’s high-profile campaign.

It was not the only controversy the election has seen. While anyone in the world can vote, Forest & Bird now requires electors to verify their ballots after foreign interference plagued the contest before. In 2018, Australian pranksters cast hundreds of fraudulent votes in favor of the shag.

The following year, Forest & Bird was forced to clarify that a flurry of votes from Russia appeared to be from legitimate bird-lovers.

While campaigns are fiercely competitive, managers described tactics more akin to pro wrestling — in which fights are scripted — than divisive political contests.

“Sometimes people want to make posts that are kind of like beefy with you and they’ll always message you and be like, hey, is it okay if I post this?” Bull said. “There is a really sweet community. It's really wholesome.”

This story corrects percentage to 1% instead of 10%.