If you've ever watched a child with a severe food allergy navigate a birthday party, a school canteen, or a family barbecue, you understand the constant, low-level dread that follows families wherever they go. The EpiPen has been the lifesaving companion for millions of Australians for decades — but for many, the prospect of jabbing a needle into a child's thigh in a moment of panic is itself a barrier to timely treatment. A new option has arrived, and it could change things.
neffy, an adrenaline (epinephrine) nasal spray developed by ARS Pharmaceuticals and distributed in Australia by CSL Seqirus, was registered by the Therapeutic Goods Administration (TGA) on 8 December 2025 and became available by private prescription in early 2026. It is the first adrenaline nasal spray approved for use in Australia, and the first significant new delivery method for anaphylaxis treatment in more than 25 years. For the allergy community, that is a genuinely big moment.
Why a Needle-Free Option Matters
Australia's relationship with food allergy is, frankly, alarming. Australia has the highest reported rates of childhood food allergy in the world, with one in ten babies and one in twenty primary school-aged children affected. Between 2015 and 2020, Australian public hospitals recorded a 51 per cent increase in emergency department presentations due to anaphylaxis, and a 35 per cent rise in hospitalisations. These are not abstract statistics — they represent families living under constant threat.
The trouble with the existing standard of care is not that adrenaline autoinjectors don't work. They do. Rapid administration of epinephrine is the only approved first-line treatment for severe allergic reactions or anaphylaxis. The problem is that people delay using them. Despite epinephrine's well-established history of safety and efficacy, patients and caregivers have reported significant reluctance to administer it, largely owing to concerns about the injection. Research has found that up to 83 per cent of patients and caregivers fail to administer or delay using epinephrine autoinjectors, even when they recognise a severe allergic reaction is occurring. That hesitation can be fatal. The most common cause of death from anaphylaxis is when adrenaline has not been administered, or there has been a delay in its administration.
neffy addresses this by removing the needle entirely. It delivers adrenaline via a nasal spray device, with adrenaline entering the bloodstream through the nasal mucosa. A phase 3 study in paediatric patients found that median time to symptom resolution was 16 minutes, and no patients required a second dose of epinephrine for treatment of the initial reaction. The Australasian Society of Clinical Immunology and Allergy (ASCIA) has updated its 2026 Action Plans for Anaphylaxis to include the nasal spray as a recognised device option.
Who Can Use It — and Who Can't
This is where the picture becomes more complex. neffy is approved for adults and children weighing 15kg or more, aged four years and over. That covers a large portion of the at-risk population, but not all of it. Adrenaline nasal spray cannot be used in children who are under four years of age and/or under 15kg, whereas adrenaline autoinjectors provide a treatment option in this group. Parents of very young children will still need to rely on traditional devices.
There are other limitations worth understanding. neffy carries a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption. There is also a concern about using it during an allergy attack that causes swelling, since the nasal cavity can swell up too, which could in theory block delivery of the drug. Clinicians recommend that anyone considering neffy discuss their individual circumstances with an allergist first.
Common side effects reported following neffy in Australian prescribing information include headache, nasal discomfort, throat irritation, and feeling jittery. These are generally mild and consistent with the pharmacological effects of adrenaline.
The Cost Question
Here is where fiscally minded Australians — and frankly, most families — will want to pay close attention. neffy is a Schedule 4 prescription-only medicine, currently available via private prescription. That means, for now, patients pay the full private price at the pharmacy. CSL Seqirus has submitted an application for neffy to be subsidised on the Pharmaceutical Benefits Scheme, with that submission set to be considered at the March 2026 Pharmaceutical Benefits Advisory Committee meeting.
Until a PBS listing is secured, affordability will be a genuine concern for many families, particularly those already bearing the considerable ongoing costs of managing severe food allergy. The launch of neffy marks the first time in over 30 years that a new way of administering adrenaline has been approved in Australia — which is precisely why advocates are pushing hard for PBS support. A treatment option that exists only for those who can afford private prescription prices is not adequate public health policy.
A Welcomed Innovation, With Appropriate Caution
The allergy community's response has been warm but measured. Professor Connie Katelaris AM, a leading NSW allergist, has welcomed the additional option for care, noting that neffy has been available overseas and that Australian patients will now have access. The availability of a needle-free epinephrine delivery device may reduce dosing hesitancy, particularly in patients who are fearful of injections. That is not a trivial benefit; it could save lives.
But clinicians are careful not to overstate the case. The approval of the nasal spray was based on clinical studies in which patients did not have anaphylactic symptoms when neffy was administered, due to ethical and practical barriers. This means the real-world efficacy data is still accumulating. Researchers and clinicians broadly agree that further research is necessary to fully assess the long-term safety and efficacy of neffy. The recommendation from most allergists is that patients consult their specialist before switching devices, and that those with nasal conditions or very young children should maintain access to an autoinjector.
The short version: neffy is a genuine and welcome innovation for Australian families living with severe food allergy. Its limitations are real, its evidence base is still developing, and its cost remains a hurdle until PBS listing is confirmed. For families who are eligible, a conversation with your doctor about whether it suits your circumstances is absolutely worth having. And for policymakers, the March 2026 PBAC decision will be the test of whether this breakthrough treatment reaches the people who need it most — not just those who can afford it.