neffy delivers epinephrine through a nasal spray instead of injection
of ConsumerAffairs
If you're unlucky enough to suffer from severe allergic reactions that require life-saving intervention, it should be good news that there's a new nasal spray that can replace the injections that have previously been recommended.
The U.S. Food and Drug Administration recently approved neffy, an epinephrine nasal spray for consumers suffering anaphylaxis. Until now, the standard treatmentwas an automatic injector that was bulky and expensive -- and difficult to use for children and people fearful of injections.
"Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections, said Kelly Stone, MD, PhD, in the FDAs Center for Drug Evaluation and Research. Neffy provides an important treatment option and addresses an unmet need.
Allergic reactions happen when a persons immune system reacts abnormally to a substance -- food, insect bites, etc. -- that normally donot cause symptoms. Anaphylaxistypically involves multiple parts of the body and is considered a medical emergency.
Symptoms usually occur within minutes of exposure and include hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection, using an EpiPen or other portable device.
Neffy is a single-dose nasal spray administered into one nostril. A second dose can be given if needed.
Learn more about anaphylaxis
The American Academy of Allergy, Asthma and Immunology has an interactive guide to anaphylaxis. Click here to see it.
Results of neffy tests
Neffys approval is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products.
Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis.
A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.
Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, and patients with these conditions should consult with a health care professional to consider use of an injectable epinephrine product. Neffy also comes with warnings and precautions about use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite.
Photo Credit: Consumer Affairs News Department Images
Posted: 2024-08-16 19:54:36
