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)
MULTAN, Pakistan (AP) — England is aiming to challenge struggling Pakistan with a new-look pace attack in the opening test of a three-match series, starting in the searing heat of Multan on Monday.
Fast bowler Brydon Carse will make his test debut with Gus Atkinson set to play his first overseas test after his impressive home season against the West Indies and Sri Lanka.
All-rounder Chris Woakes was penciled in to the starting XI after Ben Stokes was ruled out for the fourth successive test match due to ongoing rehabilitation on his injured hamstring. Woakes will be playing his first match in two-and-a-half years and it will be his first test in Asia since 2016.
Carse’s pace gave him the edge over Olly Stone and Matthew Potts for the tour of Pakistan and England hopes the Durham pace bowler will challenge the batters by regularly clocking over 90mph.
England will be led by Ollie Pope, who guided the team to a 2-1 home series against Sri Lanka in the absence of the injured Stokes. The England captain sustained his hamstring injury during the Hundred and might return to lead the side in the second test, also in Multan.
“I was kind of just learning on the job,” Pope said. “Obviously my first time captain abroad. Ben’s going to be around as well… so I can listen to the voices around me but still keep doing things in my way.”
England flattened Pakistan 3-0 through its high-risk, high-reward “Bazball” approach during the 2022 tour when it played at Multan, Karachi and Rawalpindi.
They were scheduled to play at the same venues this time around, but renovation work at the National Bank Stadium in Karachi for next year’s Champions Trophy forced the Pakistan Cricket Board to organize back-to-back tests at Multan with Rawalpindi set to host the third test from Oct. 24.
England also named spinners Jack Leach and Shoaib Bashir in the playing XI in anticipation of the pitch flattening out in temperatures of 40 degrees Celsius that are expected over the next week in Multan. Leach was the second highest wicket-taker in the last series in Pakistan with 15 wickets.
“Everyone’s so happy to have Leach in and around the squad for this series,” Pope said. “We obviously saw how well he bowled last time here on pitches that (are) always offering a great deal ... and he’s worked closely with Shoaib Bashir throughout his Somerset career and those guys go really well.”
Pakistan has strengthened its batting line-up by including all-rounder Aamer Jamal for the first test after being routed 2-0 by Bangladesh at home in the last series. Shan Masood has lost all five test matches since he was elevated to red-ball captain.
Masood lost 3-0 to Australia in his debut series as test skipper when Jamal took 18 wickets and came in handy as a batter down the order. Jamal missed the series against Bangladesh because he was undergoing rehabilitation on a back injury.
“We have got an edge with the return of Aamer Jamal,” Masood said. “He also bats down the order and picked up 18 wickets. We have (leg-spinner) Abrar and (off-spinner) Salman to give us spin options.”
Pakistan has a woeful record in home test matches and hasn’t won at home since beating South Africa 2-0 in early 2021, while losing to England, Australia and Bangladesh. New Zealand also came close, but Pakistan managed to draw the series 0-0.
Pakistan had its moments to beat England when both teams last met at Multan two years ago. Leg-spinner Abrar Ahmed made an impressive debut by grabbing 11 wickets before Pakistan narrowly lost by 26 runs when Mark Wood, missing in this series due to injury, claimed the key wicket of Saud Shakeel.
“It was my dream debut and last time we lost quite close,” Abrar said on the eve of the first test. “I hope to give a match-winning performance this time around and bring some happy moments.”
Pakistan's top-order batters have long been struggling and premier batter Babar Azam hasn’t scored a half-century in his last 16 test innings. Opener Abdullah Shafique also struggled against Bangladesh while Masood couldn’t convert starts into big scores with only one half-century in four innings.
But Masood insisted Pakistan needed to give its struggling batters a longer run as he searched to win key moments and find momentum in the series against aggressive England.
“We came close to winning last time, but we let the matches slip away,” Masood said. “We know how they play, but at the end of the day we have to see how to tackle it. We are clear in our mind and that’s why we have named the XI.”
AP cricket: https://apnews.com/hub/cricket
Pakistan's test team's head coach Jason Gillespie, center right, examines the pitch preparing for 1st test cricket match between England and Pakistan, as England's coach Brendon McCullum, right, watch, before a practice session, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
Pakistan's test team skipper Shan Masood, left, and his England's counterpart Ollie Pope pose arrive for a photo shoot with test series trophy, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
England's skipper Ollie Pope speaks during a press conference regarding 1st test cricket match against Pakistan, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
Pakistan's test team skipper Shan Masood speaks during a press conference regarding 1st test cricket match against Pakistan, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
Pakistan's test team skipper Shan Masood, right, and his England's counterpart Ollie Pope pose for photograph with test series trophy, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
England team's Brendon McCullum, center, in glasses, briefs in a team meeting prior to practice session, in Multan, Pakistan, Saturday, Oct. 5, 2024. (AP Photo/Anjum Naveed)
England's Olly Stone, left, briefs a bowling technique to Brydon Carse during a practice session, in Multan, Pakistan, Saturday, Oct. 5, 2024. (AP Photo/Anjum Naveed)
Pakistan's test team skipper Shah Masood, left, chats with test team's head coach Jason Gillespie during a practice session, in Multan, Pakistan, Saturday, Oct. 5, 2024. (AP Photo/Anjum Naveed)
Pakistan's test team's head coach Jason Gillespie, left, chats with England's coach Brendon McCullum, second right before a practice session, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
Pakistan's Sarfaraz Ahmed, second right, chats with teammates as they examine the pitch preparing for 1st test cricket match between England and Pakistan, before a practice session, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
England's coach Brendon McCullum, second right, examines the pitch preparing for 1st test cricket match between England and Pakistan, before a practice session, in Multan, Pakistan, Sunday, Oct. 6, 2024. (AP Photo/Anjum Naveed)
