FDA approves nasal injection epinephrine for aAnaphylaxis, reaction

Aug. 9 (UPI) -- The U.S. Food and Drug Administration on Friday announced the approval of the first nasal spray for treatment of anaphylaxis, a life-threatening allergic reaction.

The epinephrine nasal spray is now approved for emergency treatment of Type I allergic reactions including anaphylaxis in adult patients weighing a minimum of about 66 pounds (30 kilograms), the FDA said in a statement Friday.

Epinephrine is the only available treatment for anaphylaxis and was previously only available as an injection. The injection is commonly referred to by its brand name EpiPen , which is owned by Pennsylvania-based Mylan Inc. Generic versions also are available.

The new nasal spray is being dubbed Neffy by the FDA and was developed by ARS Pharmaceuticals.

The California-based company said one of the reasons behind the treatment was to make epinephrine more accessible to patients, particularly those with trouble using injection drugs.

"Our nasal spray may help reduce hesitation and allow patients to confidently administer when needed," the company says on its website.

A Type I allergic reaction or Type I hypersensitivity is "an immediate reaction and involves immunoglobulin E (IgE) mediated release of antibodies against the soluble antigen. This results in mast cell degranulation and release of histamine and other inflammatory mediators," according to a National Institutes of Health definition.

The cause of the reaction is exposure to various types of antigen or foreign substance.

Common antigens can include food and nut allergies, as well as bee, wasp or other insect stings and bites.

Like the injection, Neffy is a single-use treatment and the spray is administered into one nostril. Patients may require further medical treatment at a hospital or other care facility depending on the severity of their allergic reaction.

"Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," FDA Associate Director of Pulmonology, Allergy and Critical Care Kelly Stone said in the agency's statement.

"The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need."