ARS Pharmaceuticals Submits sNDA to FDA for neffy® 1 mg Dose for Children 15-30 kg with Type I Allergies

ARS Pharmaceuticals, Inc. has announced the submission of a supplemental New Drug Application (sNDA) for their product neffy® 1 mg. This product is targeted at treating Type I Allergic Reactions, including anaphylaxis, in children weighing between 15 to 30 kg (33-66 lbs.). This submission follows the FDA's approval of neffy (2 mg) for treating similar allergic reactions in adults and children weighing 30 kg (66 lbs.) or more, granted on August 9, 2024.

The pharmacokinetic (PK) data for neffy 1 mg indicates that it is slightly higher than that observed in adults who receive the same dosage. However, the pharmacodynamic (PD) response is comparable. Food allergies impact around six million children in the U.S., with more than 40 percent experiencing severe allergic reactions such as anaphylaxis. Studies have shown that two-thirds of children fear needles, and over half of parents are anxious about using their child's epinephrine auto-injector, a potentially lifesaving treatment.

Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals, highlighted the significance of neffy 1 mg, stating, "Fear of needles often prevents children from accepting treatment with auto-injectors. If approved, neffy 1 mg will be the first needle-free epinephrine option for younger children and the first new delivery method for this group in over 35 years." He emphasized the need for innovative treatments like neffy 1 mg, noting that almost half of all current epinephrine auto-injector prescriptions are for children, particularly those weighing between 15 to 30 kg.

The data submitted to the FDA underscore several benefits of neffy 1 mg:
- It eliminates the risk of needle-related adverse events, such as accidental injections into the hands or fingers, which occur about 3,500 times annually in the U.S., predominantly affecting pediatric patients.
- Its simple insert and press mechanism delivers epinephrine almost instantly without requiring a hold time in the nose.
- Human factor studies demonstrated that adults with no prior knowledge of the disease or device, such as babysitters or teachers, could successfully use it by following instructions. Additionally, untrained children as young as 10 years old were able to self-administer neffy.
- Neffy can withstand temperature exposures up to 122°F (50°C) and can be used even if accidentally frozen and then thawed.

Eleanor Garrow-Holding, President, and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT), praised neffy 1 mg, stating, "This innovation is undoubtedly going to save lives. Patients need options, and neffy helps address that issue." She emphasized the importance of making neffy 1 mg available as soon as possible to ensure the safety of children with food allergies.

Type I severe allergic reactions, including anaphylaxis, are serious and potentially life-threatening events that require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors are highly effective, their limitations often result in patients and caregivers delaying or not administering the treatment in emergencies. These limitations include fear of needles, lack of portability, needle-related safety concerns, and the complexity of the devices. In the U.S., around 40 million people experience Type I severe allergic reactions due to food, venom, or insect stings. However, only 3.3 million have an active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even with an auto-injector, more than half of the patients or caregivers delay or fail to administer it in emergencies.

ARS Pharmaceuticals, Inc. is dedicated to empowering at-risk patients and their caregivers to better protect against severe allergic reactions. The company is commercializing neffy® 2 mg (trade name EURneffy in the EU), an epinephrine nasal spray for patients weighing 30 kg or more with Type I allergic reactions, including those caused by food, medications, and insect bites that could lead to life-threatening anaphylaxis.