The US Food and Drug Administration has approved an update to the prescribing information for epinephrine nasal spray (neffy), removing the minimum age requirement for the 1 mg dose and expanding access to younger pediatric patients who meet weight criteria, according to a press release from ARS Pharmaceuticals.
Neffy is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients weighing 33 pounds or greater. The update removes the previous minimum age requirement of 4 years for use of the 1 mg dose in patients weighing 33 to less than 66 pounds.
According to ARS Pharmaceuticals, approximately one-quarter of patients requiring epinephrine fall within the 33- to less than 66-pound weight range, including about 25% who are younger than 4 years. Caregivers often report fear of needle-based treatment options, and many patients and caregivers delay or do not administer treatment in emergency situations, the company said.
Additional labeling revisions include updated guidance on storage, handling, and administration. The label recommends that patients carry two neffy devices and keep them in their blister packaging or a designated carrying case, which the manufacturer plans to include with each prescription beginning in summer 2026.
Updated administration guidance indicates that sniffing after dosing does not affect management. If symptoms improve, a second dose may not be necessary; however, if symptoms persist or worsen, a second dose should be administered starting 5 minutes after the first dose using a new device. Patients should seek emergency medical care following use as appropriate. The product may be used after thawing if frozen and remains stable during temperature excursions up to 122 °F.
Neffy is available in two dose strengths: 1 mg for patients weighing 33 to less than 66 pounds and 2 mg for those weighing 66 pounds or greater.
Type I allergic reactions, including anaphylaxis, can develop rapidly and may be life-threatening, requiring prompt treatment with epinephrine. Many patients do not routinely carry prescribed auto-injectors, and a substantial proportion delay or do not use them during an allergic emergency, according to ARS Pharmaceuticals.
Source: ARS Pharmaceuticals