Nasal Spray for Treatment of Anaphylaxis Approved by FDA
Neffy is the first epinephrine product that does not need to be administered by injection and the first new epinephrine delivery method in 35 years. It will be available at a starting price of $25.
The FDA approved ARS Pharmaceuticals neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions, according to a news release published today.
Anaphylaxis is a severe, life-threatening allergic reaction that can be caused by foods such as shellfish, tree nuts or insect stings. Symptoms can appear as hives, itching, vomiting, difficulty breathing and loss of consciousness. The only treatment for anaphylaxis is epinephrine, which was previously only administered via injection.
The recommended use of neffy is a single dose spray of 2mg into one nostril. If symptoms do not improve within five minutes, another spray may be given in the same nostril. It is approved for patients who are at least 66 pounds, giving those with a fear of needles a less frightening alternative to traditional epinephrine injections.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, M.D., Ph.D., 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.”
This approval is based on the results of four studies of 175 adults with type 1 allergies without anaphylaxis. Effectiveness was measured by calculating epinephrine concentrations in the blood following use.
The most common side effects reported were throat irritation, reported by 2% of participants after one dose and 19% after two doses, headache reported by 6% after one dose and 18% after two doses and nasal discomfort, reported by 10% after one dose and 13% after two doses.
ARS Pharma will make neffy available to insured patients for $25. One filled prescription contains two single-use neffy devices. For eligible but uninsured individuals, neffy will cost $199 via digital pharmacy service BlinkRx or GoodRx. Some individuals may also be able to get neffy for free through the ARS Pharma Patient Assistant Program.
ARS Pharma will host an investor conference call on Aug. 12, 2024, at 8:00 a.m. ET.
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