The Food and Drug Administration approved the NEFFY EPINEPHRINE spray to treat the serious allergic reactions of children under 4 years of age. Nasopray is the first required epinprin treatment in the United States for 30-66 pounds with food, drugs and stab allergies in the United States.
Dr. David Fleischer, the chief of allergies and immunologists in Children’s Hospital Colorado, said, “Many people are waiting for the first defense because they are given epinephrine until symptoms progress or fear of antihistamines. “Feed”S Small user -friendly designs solve these tasks so that people can actually carry Epinephrine and act quickly and confidently during allergic emergencies. ”
Neffy sprayers, created by ARS Pharmaceuticals, contain an epinephrine of 1 milligram (Mg) capacity. NEFFY 1 mg must be available at the pharmacy by the end of May 2025.
Richard Lowenter, the president and CEO of ARS Pharma, said 1mg Neffy for small children, “provides a long -awaited alternative to the family.” About one out of 13 American children has food allergies.
Lowentshaal said, “I think that 1 mg will reduce access to options without needles for severe allergic treatment and reduce hesitation in treating these vulnerable groups. “We will also eliminate dangers such as accidental needle injuries to children and caregivers.”
Neffy for young children: hesitant
The approval of the low -dose sprayer was seven months after the FDA approved 2 mg of NEFFY dose, which was an alternative without the needle of automatic injection. The higher dose is for adults and children of 66 pounds or more.
The Food Allergic Community celebrated the approval. According to the Food Allergy Research & Education, the addition of NEFFY 1 mg dose expands the advantages of an option without needles for 5.6 million children in the United States.
Fare’s CEO SUNG POBLETE and RN said, “Neffy’s availability for young children can help to reduce hesitation and anxiety among parents, caregivers and children, making it easier to manage treatment without delay when anaphylaxis is suspected. “The principle of ‘EPI FIRST, EPI FAST’ is important for reversing the anaphylaxis, and we recognize NEFFY as an important resource for the food allergic community.”
Epinephrine is the only drug that can stop anaphylactic. However, research shows that epinephrine is underestimated in a serious allergic reaction.
According to a survey, some parents often do not recognize them as serious symptoms, or they first turn into antihistamines. Some also feel tension about the use of automatic syringes, and many do not always carry two automatic syringes as recommended.
Study on NEFFY’s approval
Photo: ARS Pharma
NEFFY’s approval for young children is based on several studies, including both adults and pediatric patients under 4 years of age. The results showed that the peak concentration is similar among various methods.
The study also assessed the changes in blood pressure and heart rate, the main indicator of epinephrine absorption. This study has found similar growth among all epinephrine delivery methods.
ARS also conducted a “human element study” showing that children under 10 years of age can manage NEFFY themselves. “Even individuals who are not trained, such as baby sitters or teachers, can effectively manage NEFFY,” Lowenthal says.
To manage Neffy for children, put a spray into the nose hole and press. Like 2mg Neffy, the sprayer should not be primary. After the epinephrine is released, there is no need to hold on to the nose.
“The main consideration of the allergic emergency is to try to calm the subject and take it quickly. Lowenthal says.
The side effects of pediatric exams were generally mild. Common side effects include nose discomfort, headache, throat irritation, chest and nasal congestion, neurological, nosebleeds, dizziness, nausea and vomiting.
The current FDA approval for 1mg capacity is reduced to 4 years old. But Lowenthal says that if the FDA later collects more data, it can extend it to young children with a weight of 30 pounds.
Neffy for parents and infants?
Older children account for about two -thirds of NeFy sales after 2mg sprayers are available. Lowenthal said, “Children are more likely to be an adapter because they don’t like car syringes more than anyone else.
He expects a similar enthusiasm among parents for 1 mg dose. “We continued to be requested from the day of approval (2 mg dose) when we had one for young children.
ARS Pharma also develops smaller doses for children less than 30 pounds. The company is starting researching small doses of babies and infants in cooperation with the FDA and European regulators.
Lowenthal is one of the tasks to recruit very young children. Therefore, ARS Pharma hopes that the absorption of epinephrine and computer modeling in the body can replace the infant’s test. They are also trying to modify the sprayer to fit a small nose.
“We do not forget young children. We are trying to do it. ”Lowenthal says.
Neffy for children: cost and availability
NEFFY 1 mg of young children over 4 years old is expected to be available in pharmacies in May. Join the 2mg sprayer already available for older children and adults.
Patient coupon. For those who do not have an insurance coverage, the cash price of 2 packs is $ 199. coupon.
You can also order NEFFY neffy.com. On the website, the patient can upload a NEFFY sprayer prescription and receive the drug by mail from BLINKRX. If you need a prescription, you can go to Neffy.com and make an appointment with a remote health provider for $ 35.
ARS Pharma also has a patient support program that provides free NEFFY to qualified individuals.
NEFFY is now included in the prescription formula of several countries and local commercial insurers. This includes Express Scripts, Optum RX, Tricare, Cigna Healthcare and Navitus Health System. Lowenthal said more additions would be added.
In the case of insurance officials that do not yet include NEFFY, doctors may request pre -approval for patients. ACAAI allergic organization was created This letter generator To help. ARS pharma facilitates this for patients who ordered the drug via neffy.com.
Storage life, school approach
NEFFY ‘s has a valid period of 24 months at room temperature. (2mg Neffy has a slightly longer expiration date for 30 months).
The drug can withstand the temperature up to 122 degrees for up to three months and still maintains a lot of power. If it is frozen by mistake, ARS says NEFFY can thaw without damaging effects or devices.
ARS Pharma also launched NEFFYINSCHOOLS, which provides free epinephrine sprayers to K-12 public and private schools to use for allergic emergencies. Lowenthal says both dose will be part of the school program.
However, in some states, legislation or regulatory updates are required to allow nasal epinephrine together. Stock Epinephrine Automatic syringe. POBLETE said NEFFY 1 mg dose said, “We hope to help increase access to childcare facilities across the United States and school classes.
UK, Canada and European plans
ARS Pharma has been approved by 2mg sprayers in Canada and the United Kingdom. In that country, it will be called EURNEFFY and will be sold by the pharmaceutical company Alk-Abelló.
Lowenthal said it is expected to be approved in England and Canada this summer.
In August 2024, the European Commission approved 2mg EURNEFFY. Emergency treatment of allergic reactions of the European Union. The approval of 1 mg is expected by the end of 2025.
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