A nasal spray that is an alternative to shots for people with severe allergic reactions may soon be available in the United States.
The Food and Drug Administration has approved ARS Pharma’s Nephi (sold without capital letters) for adults and children weighing 66 pounds or more who suffer from a dangerous allergic reaction called anaphylaxis, which normally requires an epinephrine shot.
The company says the product is expected to be available within the next eight weeks.
Severe allergies may be related to foods, medicines, insect bites, etc. Symptoms of anaphylaxis include difficulty breathing or swallowing, hives, swelling, convulsions, nausea, rapid pulse, and low blood pressure. Anaphylaxis can be fatal. Medscape reported Two percent of Americans, or about seven million people, are at risk of experiencing anaphylaxis at some point in their lives.
How Nephi works
ARS Pharma News Release “Nephi offers adults and children who suffer from severe allergic reactions a new way to administer epinephrine for the first time in over 35 years,” the company said, highlighting the need for an injection-free method of epinephrine administration, as many people are averse to injections, leading to delayed or no treatment, which can lead to dire, even fatal, outcomes.
The company’s announcement included a statement from Dr. Thomas B. Casale, director of clinical and translational research and professor of medicine and pediatrics in the Department of Allergy and Immunology at the University of South Florida: “The FDA approval of Nephi means that patients with severe allergies finally have a long-awaited, needle-free, portable method of epinephrine administration that potentially reduces administration time, potentially leading to better clinical outcomes and improved quality of life for patients and their caregivers.”
Medscape reports that “Nephi is taken as a single spray into one nostril. A combined study of four studies in 175 healthy adults showed that the product can achieve similar blood epinephrine levels as those achieved by injection, with similar increases in blood pressure and heart rate. In a study of children weighing 66 pounds or more, blood levels after taking Nephi were similar to those seen in adults using the product.”
According to the article, “The FDA recommends that people with any nasal medical condition or history of nasal surgery should talk to a health care professional before using Nephi. The product may also be unsafe for people with certain other medical conditions or sulfite allergies.”
ARS Pharma notes that about 500,000 people visit emergency rooms each year with life-threatening allergic reactions, and in most cases, epinephrine injections are not administered before arriving at the hospital.
How much does Nefi cost?
The company said it “will offer a robust program to support patient access” and will cap the cost of two prescriptions at $25 for most people who have insurance that covers Nephi. “For eligible patients who are uninsured, in situations where their health plan does not yet cover Nephi, or in situations where patients face high out-of-pocket costs due to high-deductible plans, ARS Pharma will offer two doses of Nephi at the cash price of $199 via BlinkRx, a digital pharmacy service available to patients at no additional charge.”
The price also applies to people who use pharmacies through GoodRx or whose insurance plans don’t cover Nephi. There is a patient assistance program that provides Nephi at no cost to uninsured or underinsured patients who “meet certain eligibility criteria and have exhausted all other options,” the release said.
