Australians with severe allergies now have a needle-free alternative to the Epi-pen in an Australian first.
The Therapeutic Goods Administration approved an adrenaline (epinephrine) nasal spray in December and the product, marketed as neffy, is expected to be available from February.
Allergists have welcomed patients having access to more treatment options. Patient advocate group Allergy and Anaphylaxis Australia is hopeful the product will help address unmet patient needs.
The product has been approved for treating anaphylaxis in adults and children aged four years and over weighing more than 15kg.
The introduction of neffy, the only adrenaline nasal spray approved for use in Australia, represents the first significant innovation in anaphylaxis treatment in more than 25 years.
It delivers the same active ingredient used to treat anaphylaxis in Epi-pens. Using a nasal spray device similar to that used in opioid reversal medicine, the epinephrine is delivered through the nasal mucosa, allowing it to readily enter the bloodstream.
Allergist Professor Connie Katelaris said allergic diseases like anaphylactic reactions place a significant burden on patients and the broader system.
“Allergic diseases, impact about 30% of Australians and place significant financial, social and emotional strains on patients, carers and the broader community,” she said.
“Anaphylaxis is the most severe form of allergic reaction and access to more treatment options is welcomed.
“The introduction of neffy for anaphylaxis treatment and management is an important step in helping reduce the burden of disease.”
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The Australasian Society of Clinical Immunology and Allergy (ASCIA) is in the process of updating training and resources to support healthcare professionals and the community.
ASCIA Anaphylaxis Committee Chair Associate Professor Kristina Rueter said the product’s registration represented a significant change in anaphylaxis management.
“The introduction of a new adrenaline device for the treatment of anaphylaxis represents the biggest change in the space in over two decades,” she said.
She said adrenaline should be prescribed with an anaphylaxis management plan which includes an ASCIA Action Plan.
“We’ve been working hard to ensure management guidelines and action plans will be updated to ensure healthcare professionals and the wider community are supported as the anaphylaxis treatment landscape evolves,” she said.
Australia has one of the highest documented rates of anaphylaxis hospital admissions in the developed world.
Between 2015 and 2020, Australian public hospitals reported a 51% increase in emergency department presentations and a 35% increase in hospitalisations due to anaphylaxis.
Sarah Emery, from Allergy and Anaphylaxis Australia, said that the availability of neffy could help address unmet patient needs.
“Without prompt treatment anaphylaxis can be fatal. Despite this we know that many patients delay or do not administer treatment for a number of reasons, including a lack of confidence in administration, issues with devices, and, in some cases, because they do not carry an adrenaline device,’ she said.
“For patients there is no one size fits all solution when it comes to treatment administration. The availability of a differentiated option may help remove barriers to timely self-administered treatment for anaphylaxis, will be welcome news for healthcare professionals, patients and carers.”
neffy is available to patients on a private prescription
Australian biotechnology company CSL Seqirus has submitted an application for neffy to be listed on the Pharmaceutical Benefits Scheme, which is expected to be considered in March.
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