The updated label for the Neffy 1 mg dose allows children weighing at least 33 pounds to access the needle-free treatment regardless of age.
RT’s Three Key Takeaways:
- Age Requirement Removed: The FDA approved a label update for neffy 1 mg that removes the previous 4-year-old age minimum, allowing any patient weighing between 33 and 66 pounds to use the nasal spray.
- Needle-Free Access: The removal of the age restriction expands access to a needle-free epinephrine option for younger children who meet the weight criteria, addressing caregiver concerns regarding needle-based injectors.
- Updated Handling Guidance: New labeling provides more flexibility for storage, allowing for temperature excursions up to 122°F and use after thawing if the device is accidentally frozen.
The US FDA has approved a label update for neffy 1 mg (epinephrine nasal spray) that removes the age requirement for the emergency treatment of Type 1 allergic reactions, including anaphylaxis.
Previously, pediatric patients were required to be at least 4 years old and weigh between 33 and 66 pounds to receive the 1 mg dose. Under the new guidelines, any adult or child weighing 33 pounds or more can utilize the needle-free treatment, according to a news release from ARS Pharmaceuticals.
“We are very pleased that based on clinical data presented to FDA for neffy, that the Agency removed the age requirement in the indication,” said Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, in a news release. “Caregivers often face tremendous fear administering needle-based treatment options but now, neffy can be used safely in our most vulnerable young patients (≥33 lbs. and <66 lbs.), without age restrictions.”
Approximately 25% of patients requiring epinephrine are children weighing between 33 and 66 pounds, and about 25% of that group is under the age of 4, according to the company.
“Severe allergic reactions are a major concern in early childhood and parents often delay treatment because they are afraid of hurting their child with a needle-injector or accidentally injecting themselves,” said Dr Nicole Chase, MD, allergy/immunology and pediatrics, in a news release. “Having a needle-free epinephrine treatment available for anyone who meets the weight criteria is an important step forward, in broadening access, lowering treatment hurdles, and supporting caregivers who are doing everything they can to protect their children.”
The FDA also updated the label with more flexible guidance regarding sniffing and storage. The new language explains that management of an allergic event remains the same even if a patient sniffs after dosing. Additionally, neffy can be used once thawed if accidentally frozen, and high temperature excursions up to 122°F are now permitted.
Neffy is available in two doses. Neffy 1 mg is intended for patients weighing between 33 and 66 pounds, while neffy 2 mg is the recommended dosage for children and adults weighing 66 pounds or more.
The updated labeling recommends storage in the original blister packaging or a carrying case. ARS Pharma currently offers free cases and plans to include them in prescription cartons starting this summer.
