First Needle-Free Allergy Treatment Wins Approval

Many people suffer from mild or seasonal allergies, as the research, education and health information provider, Cleveland Clinic, affirms. But a much smaller percentage of the global population is vulnerable to severe allergic reaction, or anaphylaxis, which can be life-threatening. These people have to date relied on ensuring quick access to auto-injectors administering epinephrine (adrenaline) treatment such as an EpiPen, which need to be quickly injected into the outer thigh after symptoms appear.

For these people, and their families, the existence of a new nasal spray, just approved by the FDA, according to its media release, that can deliver this medication in a far more convenient and well-tolerated way, will come as very welcome news indeed, as AP reports.

What is anaphylaxis?
Anaphylaxis is a severe, life-threatening allergic reaction that can occur seconds or minutes after an individual is exposed to something they are allergic to, for instance insect stings, nuts or other foods, latex, or medications, as the Mayo Clinic explains.

During a severe allergic reaction, the body’s immune system overreacts, mistakenly recognizing a foreign substance as harmful, and develops a sudden, unexpected shock response to it. Common symptoms include a drop in blood pressure, a narrowing of the airways and difficulty breathing, skin rashes, swelling, dizziness or fainting, and nausea, 

Anaphylaxis needs to be treated immediately with an injection of epinephrine, often marketed as EpiPen, with a follow up in an emergency room, or in a medical environment. 

Making the fear of needles history
Now a new nasal spray from drugmaker ARS Pharmaceuticals Inc, offers an alternative way of administering epinephrine for severe allergic reactions in adults and older children. The device, known as Neffy, AP details, could transform treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers, over 30,000 of whom report to casualty departments each year.

As the ARS pharmaceutical company details on its website, this is the first and only FDA-approved needle-free epinephrine product. It is designed for adults and children weighing at least 30 kilograms (66 pounds), and to deliver adrenaline levels within range of injectable products. Importantly, it “has demonstrated rapid onset and short time to resolution of symptoms in patients with anaphylaxis.” 

The need for a more user-friendly severe allergy treatment is clear. ARS points out the gap in education and awareness, quoting statistics showing, for instance, that only three million Americans have a current prescription for an auto-injectable adrenaline product, while an alarming 80 to 90 percent of those with prescriptions do not carry or administer epinephrine.

Welcome news for parents
Parents are proving especially enthusiastic about this first nasal adrenaline spray for emergency treatment of anaphylaxis reactions due to the commonplace fears around this needle treatment in  young children and the adults that take care of them, with patients and caregivers known to delay or avoid administering euro-injectors in emergency situations. 

Indeed, Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in the above-mentioned FDA media release that “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections…” She suggests that for this reason, “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”

As pharmaceutical company ARS emphasizes, this product, with its small size, and simple “place and press” administration, is especially aligned with what healthcare providers, caregivers,  patients and parents want, a treatment offering calm and confidence to immediately administer adrenaline with the onset of symptoms of severe allergy. 

Among the comments on the heels of a  Facebook post from Allergy UK about the FDA approval, is this talkback from mother Michelle Rebello: “I hope it gets approved in the uk and Isle of Man as it would be a game changer for primary school kids! Asked my 6yr old what she thought about the neffy and she said it would make having another anaphylactic episode less scary”

Another mom, Jill Watts, adds: “This will make a huge difference – especially for teens and young people with allergies. Neffy does not need specialist training, which is fantastic.”