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FDA approves first nasal spray to treat dangerous allergic reactions

TECH

FDA approves first nasal spray to treat dangerous allergic reactions
TECH

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.

This image provided by ARS Pharmaceuticals on Friday, Aug. 9, 2024, shows the company's Neffy nasal spray to treat severe allergic reactions. (ARS Pharmaceuticals via AP)

This image provided by ARS Pharmaceuticals on Friday, Aug. 9, 2024, shows the company's Neffy nasal spray to treat severe allergic reactions. (ARS Pharmaceuticals via AP)

KARTALKAYA, Turkey (AP) — As flames tore through a 12-story hotel at a popular ski resort in northwestern Turkey, friends Esra Karakisa and Halime Cetin stood helpless, paralyzed by the horror unfolding before them: people leaning out of smoke-filled rooms pleading for help and others making the harrowing decision to leap out.

The fire at the Grand Kartal Hotel in Kartalya, in the Koroglu mountains in Bolu province, on Tuesday left at least 76 people dead and 51 injured. It came near the start of a two-week winter break for schools when hotels in the region are filled to capacity.

“There was no one around. They were calling for firefighters. They were breaking the windows. Some could no longer stand the smoke and flames, and they jumped,” Cetin, an employee at a hotel adjacent to the Grand Kartal, told The Associated Press.

Her colleague, Karakisa said: “It was awful. We were terrified. People were screaming. The cries of children especially affected us. We wanted to help but there was nothing we could do. I couldn’t look it was so terrifying.”

Authorities have assigned six prosecutors to investigate the cause of the fire, which appeared to have started at the restaurant section on the fourth floor of of the wooden-clad hotel and spread quickly through to the upper floors.

At least nine people have been detained for questioning, including the hotel owner.

Flags at government buildings and Turkish diplomatic missions abroad were lowered to half-staff as the nation shocked by the disaster observed a day of mourning for the victims.

Only 45 of the 76 bodies have been identified so far, Interior Minister Ali Yerlikaya said late Tuesday.

One of the injured was in serious condition, while 29 others were treated and released, the Health Ministry said.

The hotel had 238 registered guests, according to Yerlikaya. The fire was reported at 3:27 a.m. and the fire department began to respond at 4:15 a.m., he told reporters.

Officials and witnesses said the rescue efforts were hampered by the fact that part of the 161-room hotel is on the side of a cliff.

According to Tourism Minister Mehmet Nuri Ersoy, the hotel underwent inspections in 2021 and 2024, and “no negative situation regarding fire competence” was reported by the fire department.

Karakisa said she eventually brought clothes and water for the survivors while others rushed to bring mattresses for people to jump onto or propped up ladders against the wall to help them escape.

Among those who placed mattresses was Baris Salgur, a cleaner in a nearby hotel.

“They were saying, ‘Please help, we’re burning!' They were saying, ‘Call the fire department,' we were trying to calm them down, but there was nothing we could do, we couldn’t get in either,” Salgur, 19, said. " It was very high, we couldn’t extend a rope or anything of course. We were trying to do the best we could.”

“People jumped from a great height, I couldn’t look. There were two women at the top floor. The flames had literally entered the room. They couldn’t stand it and jumped,” he said.

Salgur described seeing a man on the top floors holding a baby and shouting for a mattress he could throw his baby on.

"We told him to be a little calmer. He waited, then the fire department came and took them (out), but unfortunately the baby had died from smoke inhalation,” he said.

Associated Press writers Suzan Fraser in Ankara, Turkey, and Robert Badendieck in Istanbul contributed to this report.

Tightened bed sheets hang from a window of a hotel where a fire broke out at the Kartalkaya ski resort in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

Tightened bed sheets hang from a window of a hotel where a fire broke out at the Kartalkaya ski resort in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

A Turkish flag flag flies at half staff outside a hotel where a fire broke out at the Kartalkaya ski resort in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

A Turkish flag flag flies at half staff outside a hotel where a fire broke out at the Kartalkaya ski resort in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

Firefighters and emergency teams work on the aftermath of a fire that broke out at a hotel in the ski resort of Kartalkaya, located in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

Firefighters and emergency teams work on the aftermath of a fire that broke out at a hotel in the ski resort of Kartalkaya, located in Bolu province, northwest Turkey, on Wednesday, Jan. 22, 2025. (AP Photo/Francisco Seco)

Firefighters work to extinguish a fire in a hotel at a ski resort of Kartalkaya, located in Bolu province, in northwest Turkey, Tuesday, Jan. 21, 2025. (Enes Ozkan/IHA via AP)

Firefighters work to extinguish a fire in a hotel at a ski resort of Kartalkaya, located in Bolu province, in northwest Turkey, Tuesday, Jan. 21, 2025. (Enes Ozkan/IHA via AP)

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