HQ Team
August 12, 2024: ARS Pharmaceuticals, a US-based biopharmaceutical company, got the nation’s drug regulator’s approval for a nasal spray to treat allergic reactions in adult and paediatric patients.
The US Food and Drug Administration gave its nod for the company’s neffy — epinephrine nasal spray — to treat reactions including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds), according to an FDA statement.
Allergic reactions occur 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.
First spray in 35 years
Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection, according to the statement. The company stated that it was the first spray treatment after 35 years.
“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine,” said Thomas B. Casale, MD, Professor of Medicine and Pediatrics the USF Health Morsani College of Medicine’s Division of Allergy and Immunology at the University of South Florida in Tampa, Florida.
“In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment.”
According to the FDA neffy’s Fast Track approval was based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following the administration of neffy or approved epinephrine injection products.
Single-dose spray
Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Results from ARS Pharmaceutical’s 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.
Nasal surgery, polyps
“Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event, further treatment is required,” according to the FDA statement.
Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect the absorption of neffy, and patients with these conditions should consult with a healthcare professional to consider the use of an injectable epinephrine product.
Neffy also comes with warnings and precautions about the use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite.
“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.”
