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FDA Approves First Nasal Spray For Anaphylaxis Treatment

| Updated: August 21, 2024 17:40

The United States Food and Drug Administration (FDA) recently approved the first nasal spray to treat anaphylaxis, a life-threatening allergic reaction. Traditionally, such reactions are treated with an injection of epinephrine, a hormone that counteracts the allergen. Neffy is a single-dose epinephrine nasal spray used to treat allergic reactions. 

Now, with the approval of an epinephrine nasal spray called Neffy, developed by US-based ARS Pharmaceuticals, patients can manage this condition in a more painless and convenient way. Neffy is designed for the emergency treatment of type I allergic reactions, including allergies to food, medicine and insect bites. The FDA has approved the 2 mg version of Neffy for use in both adults and children weighing at least 30 kg.

Epinephrine is a hormone that relaxes muscles in the airways and constricts blood vessels, making it the only life-saving treatment for anaphylaxis. Traditionally administered via injection with emergency medical care, epinephrine treats life-threatening allergic reactions from a variety of causes, including insect bites or stings, foods, medications, and latex.

Dr Praveen Hisaria, head of clinical immunology and allergy at the Royal Adelaide Hospital in Australia and consultant at Zydus Hospital in Ahmedabad, highlighted the potential impact of Nefi, especially in low- and middle-income countries where auto-injectors are rare.

In these areas, patients often have to have adrenaline drawn and administered manually, which can be a challenging and time-consuming process.

“Epinephrine auto-injectors must be stored at specific temperatures and carried in ice packs as severe allergic reactions can occur at any time. In places like India, where patients need to be taught how to properly draw up and inject adrenaline, the nasal spray could be a game changer,” Dr Hisaria said.

Allergy consultant Dr Raj Bhagat emphasised that nasal sprays can be particularly beneficial for children. “Children are often afraid of injections and cannot inject adrenaline themselves. Parents worry that they may have anaphylaxis and may not get the exact dose they need. An easy-to-use nasal spray can ease these concerns,” he said.

The FDA’s approval of Neffy was based on four studies involving 175 healthy adults with anaphylaxis. These studies compared levels of epinephrine in the blood after using Nefi to levels after using a traditional epinephrine injection. Using Neffy resulted in similar levels of epinephrine in the blood, as well as similar effects on blood pressure and heart rate, which are important in the treatment of anaphylaxis.

Dr Hisaria said the incidence of anaphylaxis is underreported in India, partly because the condition is spread across different medical specialties and there is a lack of comprehensive studies.

“While anaphylaxis caused by toxins and drugs is well known, food-induced anaphylaxis is becoming more common in India, possibly due to globalisation and changing lifestyles. A nasal spray like Neffy is very promising in this context,” he said.

In India, the three most common allergies are foods such as nuts, milk, fish and some fruits; medications, including vaccines, anti-inflammatories and antibiotics; and insect venoms, particularly wasp and bee stings. Food allergies affect children more, while drug allergies are more common in adults.

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