SILVER
SPRING, Md., Aug. 9, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration
approved neffy (epinephrine nasal spray) for the emergency
treatment of allergic reactions (Type I), including those that are
life-threatening (anaphylaxis), in adult and pediatric patients who
weigh at least 30 kilograms (about 66 pounds).
"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,"
said Kelly Stone, MD, PhD, Associate
Director of the Division of Pulmonology, Allergy and Critical Care
in the FDA's Center for Drug Evaluation and Research. "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."
Allergic reactions happen when a person's immune system reacts
abnormally to a substance that normally does not cause symptoms.
Anaphylaxis is a severe, life-threatening allergic reaction that
typically involves multiple parts of the body and is considered a
medical emergency. Common allergens that can induce anaphylaxis
include certain foods, medications and insect stings. Symptoms
usually occur within minutes of exposure and include, but are not
limited to, 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.
Neffy's 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 is a single dose nasal spray administered into one
nostril. As with epinephrine injection products, a second dose
(using a new nasal spray to administer neffy in the same nostril)
may be given if there is no improvement in symptoms or symptoms
worsen. Patients may need to seek emergency medical assistance
for close monitoring of the anaphylactic episode and in the event
further treatment is required.
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.
The most common side effects of neffy include throat irritation,
tingling nose (intranasal paresthesia), headache, nasal discomfort,
feeling jittery, tingling sensation (paresthesia), fatigue, tremor,
runny nose (rhinorrhea), itchiness inside the nose (nasal
pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness
in the mouth (hypoesthesia oral), nasal congestion, dizziness,
nausea and vomiting.
The FDA granted neffy Fast Track designation for this
application.
The FDA granted the approval of neffy to ARS
Pharmaceuticals.
Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration