Neffy to provide a needle-free drug for severe allergic reactions

A nasal spray alternative to hypersensitive shots could soon be available in the US

The US Food and Drug Administration has approved ARS Pharma’s “neffy” – which is sold without a prescription – for adults and children who weigh 66 kilograms and have a dangerous type of allergy called anaphylaxis. Usually, they need an epinephrine shot.

The product should be available within eight weeks, the company said.

Severe allergies can be linked to food, medicine and insect bites. Symptoms of anaphylaxis include difficulty breathing or swallowing, swallowing, swelling, pain, nausea, rapid heartbeat and low blood pressure. Anaphylaxis can be fatal. Medscape reports that about 2% of the US population – about 7 million people – have a “lifetime chance of experiencing anaphylaxis.”

How neffy works

ARS Pharma said in a news release that “neffy offers adults and children living with serious illness the first new way to deliver epinephrine in more than 35 years.” The company highlighted the need for a non-injectable way to administer epinephrine, as many people are reluctant to give it to another person and sometimes treatment is delayed or not given, which can lead to side effects. terrible, even deadly.

The company’s announcement included a statement from Dr. Thomas B. Casale, professor of medicine and pediatrics and director of Clinical and Translational Research University of South Florida’s Division of Allergy and Immunology: “The FDA approval of neffy means that patients with severe allergies finally get a is a long-awaited, needle-free, convenient way to administer epinephrine that has the potential to reduce administration time, potentially leading to better clinical outcomes and improved quality of life for patients and their caregivers.”

Medscape reported that “neffy is considered a single dose sprayed into one nostril, and four studies among 175 healthy adults showed that the product can achieve the level of epinephrine in the blood similar to what you would get from a shot, as well as the same increase in blood pressure and heart rate. In a study of children weighing more than 66 kg, the blood pressure level after drinking Neffy was similar to that of adults using the product.”

According to the article, “People with other nasal conditions or a history of nasal surgery should talk to a healthcare professional about whether they should use neffy, the FDA advised, and the product also may not be safe for some people with certain conditions or allergies to sulfites.

ARS Pharma has noted that nearly half a million emergency room visits each year are the result of a life-threatening condition. Most of the time, the epinephrine shot is not given before arriving at the hospital.

How much will Neffy cost?

The company said it “plans to offer stronger programs to support patient access” and will reduce what most people with insurance cover the neffy fee to $25 for a double-use prescription. “For eligible patients without insurance, situations where the health plan does not cover neffy, or if the patient faces high out-of-pocket costs due to a highly discounted plan, ARS Pharma will offer a $199 cash price for two Neffy doses through BlinkRx, a digital pharmacy service available to patients at no additional cost.”

That price is also available to those who use retail pharmacies through GoodRx or whose insurance plans won’t cover neffy. For patients who are uninsured or underinsured and “meet certain eligibility criteria and have exhausted all other options,” it has a patient assistance program that will provide neffy free of charge, the announcement said.