ARS Pharmaceuticals Submits sNDA for Neffy to Treat Anaphylaxis in Small Children

© ARS Pharma

ARS Pharmaceuticals Inc. submitted a supplemental New Drug Application (sNDA) for a1 mg dose of nasal spray neffy, to treat type 1 emergency allergic reactions in children weighing 33 to 66 lbs., according to a news release published Monday.

Type 1 allergic reactions include anaphylaxis which 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.

In August, Neffy was approved to treat emergency allergic reactions in patients weighing 66 pounds or more. The recommended dose for that weight class is 2 mg per nostril. Pharmacokinetic data for neffy 1 mg was slightly higher in children than adults and pharmacodynamic response was about the same.

Nearly 6 million children in the United States have food allergies and more than 40% have experienced a severe allergic reaction involving anaphylaxis. Studies also show that two in three children express fear over using an epinephrine auto-injector, which could save their life.

“Fear of needles is a common reason children refuse treatment with auto-injectors,” Richard Lowenthal, co-founder, president and CEO of ARS Pharmaceuticals said in the news release. “If approved, neffy 1mg will be the first needle-free epinephrine option for younger children, in addition to being the first new delivery method for this population in more than 35 years.”

ARS listed several additional benefits in their FDA application:

• A nasal spray delivery method means there is no risk of accidental injection into the hands of a child or caregiver, which happens nearly 3,500 times a year and disproportionately affects pediatric patients.
• If neffy is accidentally frozen, it can be thawed. It can also withstand temperatures of up to 120 degrees Fahrenheit.
• Human factor studies show that children as young as 10 years old can self-administer neffy.
• Neffy delivers epinephrine almost instantly and does not need to be held in the nose.

The most common side effects from neffy in adults were throat irritation reported by 2% of participants after one dose and 19% after two doses and headache reported by 6% after one dose and 18% after two doses.

Patients interested in obtaining neffy can visit neffy.com to schedule a $35 virtual consultation with a provider or request a prescription from a current provider.

For patients with commercial insurance Neffy is available for $25 for two single-use devices. Patients with a high deductible plan, no insurance coverage or with an insurance plan that does not cover neffy can expect to pay $199 out of pocket for two doses. Neffy will be available for free for patients who have exhausted all other options.