A groundbreaking development in anaphylaxis treatment has arrived! The Therapeutic Goods Administration (TGA) has approved a game-changer: an adrenaline nasal spray called 'neffy'. This marks a significant milestone, as it's the first new adrenaline delivery method approved in Australia in over three decades. But here's where it gets controversial: is this innovative approach truly a game-changer, or just a fancy alternative? Let's dive in and explore its potential impact on therapy and patient care.
Professor Connie Katelaris, a renowned allergist, welcomes this additional treatment option, acknowledging the challenges faced by some patients with anaphylaxis. 'neffy' has been a trusted overseas solution, and now Australians have access too. But how does it compare to the well-known EpiPen?
A spokesperson from CSL Seqirus, the manufacturer, explains that 'neffy' delivers adrenaline, just like EpiPen, but with a crucial difference - no needle, no injection. Instead, it uses a similar device to opioid reversal medicines, administering adrenaline through the nasal mucosa for rapid absorption into the bloodstream.
So, can 'neffy' be included in resuscitation kits? The answer is both yes and no. While it contains adrenaline for the same purpose as injectable adrenaline in kits, it's currently classified as a Prescription-only (Schedule 4) medication, unlike the Schedule 3 items typically found in resuscitation kits.
Who benefits most from this nasal spray? It's specifically designed for emergency anaphylaxis treatment in patients aged 4 years and older, weighing 15 kg or more, offering a needle-free alternative, especially beneficial for needle-phobic individuals and young children. The medicine comes in two strengths: 1 mg for patients 15-30 kg and 2 mg for those 30 kg and above.
What should pharmacists know about its use? 'neffy' is not suitable for children under 4 years or weighing less than 15 kg, whereas adrenaline auto-injectors provide an option for this group, typically prescribing a 0.15 mg dose for children between 7.5 kg and 20 kg. It's important to note that even with conditions that increase the risk of adverse reactions, adrenaline administration is not contraindicated in life-threatening anaphylactic situations.
Who might experience adverse effects? In practice, certain individuals may be more susceptible, including those with raised intraocular pressure, severe renal impairment, prostatic adenoma with residual urine, hypercalcaemia, or hypokalaemia. Increased risk may also apply to patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, older adults, and pregnant people. Parkinson's disease patients may experience temporary worsening of symptoms like rigidity or tremor.
Who might find it challenging to use the nasal spray? The nasal route may present difficulties for some patient groups. While clinical studies included people with allergic rhinitis history, those with structural or anatomical nasal issues, such as polyps, fractures, injuries, or nasal surgery, were not part of the studies. The impact of these conditions on 'neffy' absorption is currently unknown.
Could 'neffy' be reclassified for over-the-counter sale? Potentially. CSL Seqirus has applied to the TGA for both the 1 mg and 2 mg versions to be registered as Schedule 3 medicines. This would make it more accessible and potentially reduce costs.
How much does it cost? The recommended retail price for one box of 'neffy' 1 mg or 2 mg (containing two nasal sprays) is $194, approximately 20% more expensive than EpiPen, excluding prescription consultation fees.
Will 'neffy' be listed on the Pharmaceutical Benefits Scheme (PBS)? CSL Seqirus has submitted an application for 'neffy' to be subsidised on the PBS, with the submission under consideration at the March 2026 Pharmaceutical Benefits Advisory Committee meeting. If approved, this could make 'neffy' more affordable for patients.
Where can I find more information? The Pharmaceutical Society of Australia (PSA) is updating the Australian Pharmaceutical Formulary and Handbook, including an adrenaline treatment guideline. Stay tuned for the latest developments and updates!
