A needle-less version of EpiPen for allergies hits the market, but doctors are wary : Shots

A potentially revolutionary nasal spray version of the drug epinephrine could soon be on the market as an alternative to auto-injectors like EpiPen for people with severe allergic reactions. The drug was approved this month. By FDA For use in adults and older children.

But some allergists say there’s no need to rush to prescribe them.

New needleless option: It’s called Nephi. Experts say the drug could be a cheaper, less painful and more convenient option than EpiPens, but it hasn’t yet been studied in people with a life-threatening allergic reaction called anaphylaxis, raising concerns about whether the drug will work reliably for people with severe allergies.

“We are very excited about this development, but we also have serious concerns,” he said. Dr. Robert Wood He is director of the Department of Allergy, Immunology and Rheumatology at the Johns Hopkins Children’s Center and a professor of Pediatrics at Johns Hopkins.

Anaphylaxis, also known as anaphylactic shock, is a sudden, severe, and sometimes life-threatening allergic reaction accompanied by symptoms such as shortness of breath, hives, low blood pressure, and loss of consciousness. It occurs in response to triggers such as foods, insect bites, and medicines that cause allergies.

Epinephrine is the only life-saving treatment for anaphylaxis and, until now, could only be given to patients via injection. The use of epinephrine to treat severe allergic reactions has been via needle injection since 1939, when it was approved by the FDA. EpiPen is the best-known brand of self-administered auto-injector and has been around since the 1970s. A generic version was released in 2018.

Needle substitute

Nephi was the first to be introduced as an alternative to injectable epinephrine. Clinical trials, Drug company ARS Pharmaceuticals found that the nasal spray is safe and delivers the same amount of epinephrine into the bloodstream as an auto-injector, and on August 9, the FDA approved the spray as an emergency treatment for allergic reactions, including anaphylaxis, in adults and children weighing 66 pounds or more.

Neffy, made by ARS Pharmaceuticals, may be easier to tolerate for people who don’t like injections.

ARS Pharmaceuticals

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ARS Pharmaceuticals

There are several reasons to be hopeful about epinephrine nasal spray, Dr. J. Andrew Bird He is a pediatric allergist at the University of Texas Southwestern and director of the Food Allergy Center at Children’s Medical Center of Dallas.

It may be easier to tolerate for adult patients who are reluctant to self-inject and for parents who are reluctant to inject their children.

The Nephi is about half the size of an iPhone and fits easily in a pants pocket, making it easier to carry than an EpiPen, Bird said. That alone could improve adherence and compliance with epinephrine use among people with dangerous allergies.

Currently, Only about 40% A 2023 survey of adults and children with severe allergic reactions and their caregivers found that only 30% of those most at risk actually carried an auto-injector. Participants cited inconvenience and forgetfulness as the main reasons for not carrying an EpiPen, and believed they could successfully avoid allergy triggers.

Dr. Karen Kaufman She, a physician of osteopathic medicine in Vienna, Virginia, and a member of the American College of Allergy, Asthma, and Immunology, believes that because the Nephi is small and easy to store, it could quickly replace auto-injectors in public places like schools and airplanes.

Other potential advantages of the Nephi include that it lasts longer than an auto-injector, with a shelf life of two years versus 12 to 18 months for EpiPen, according to ARS, a San Diego company that has developed the device for the past eight years. The company also says that while EpiPens will deteriorate if not stored at room temperature, the Nephi can be left in hot or cold places for months. And the Nephi is easy to use, with no training required.

Nefi added that it may be easier to administer correctly. Richard Lowenthal “We’re not just talking about a drug that’s safe for people with chronic conditions,” said Lowenthal, co-founder, president and CEO of ARS. According to Mylan, the manufacturer of EpiPen, auto-injectors can be subject to operator error. One dangerous error is injecting epinephrine into a blood vessel instead of a muscle, which can lead to stroke, arrhythmia or heart attack. In contrast, there is no risk with Nephi. Lowenthal added that ARS has verified that there is no eye harm if a user accidentally sprays the drug into their eye.

Unvalidated Concerns

But Nephi has also raised concerns among prescribers. One concern, Wood said, is that the study hasn’t been done on people who are actually having anaphylactic reactions, because researchers can’t ethically induce a fatal allergic reaction and then give patients a placebo. People with severe allergic reactions can have blocked nasal passages, Wood said. That could stop the drug from being absorbed, which could lead to unstoppable severe allergic reactions, Wood said.

Insurance coverage is also an unknown. ARS is working with major insurance companies to get Nephi on their approved drug lists, which could take about six months, Lowenthal said. The company plans to sell the spray in a two-pack, with prices depending on an individual’s means but generally around the cost of an auto-injector, he said.

The price of EpiPen has been controversial since Mylan acquired U.S. manufacturing rights in 2007 and raised the price by 600%. The average retail price for an EpiPen ranges from $650 to $750 without insurance. According to GoodRx: Generic versions cost between $150 and $200.

Alternatives to epinephrine auto-injectors are also in development: Tel Aviv-based Nasus Pharma is developing an epinephrine powder for nasal use, while New Jersey-based Aquestive Therapeutics is developing an epinephrine film to be inserted under the tongue that’s in late-stage testing, and ARS says it’s also developing a nasal spray for small children.

For now, doctors say they may avoid prescribing the new spray soon after it hits the market, in part because, like any new drug, they’ll need to spend employee time calling insurers asking for coverage, Kaufman said.

Wood said that once Nephi becomes available, which Lowenthal said will likely be late September, he will be happy to prescribe it to any patients who want it, but he also encourages them to keep an auto-injector on hand just in case.

Wood says he’ll wait to hear back on Nephi’s effectiveness. If the spray is as effective as an auto-injector at stopping dangerous allergic reactions to foods, medicines and insect bites, he says it could certainly be effective. Done It would be a game changer. “That would give us confidence,” he said.