TGA approves needle-free anaphylaxis treatment

Australia’s first needle-free option to treat severe allergic reactions is hoped to provide more choice for people at risk of life-threatening anaphylaxis.
 
The Therapeutic Goods Administration (TGA) recently approved the neffy adrenaline (epinephrine) 2 mg nasal spray vial for the treatment of anaphylaxis in adults and children aged four years and over and weighing 15 kg and over.
 
Adrenaline has been available in Australia as an injectable – such as the EpiPen – since 1993, but the approval of the first adrenaline nasal spray represents a significant step in the treatment of type 1 allergic reactions.
 
Under the new treatment, patients can access a ‘small and compact’ adrenaline device to support management of anaphylaxis.
 
Manufacturer CSL Seqirus says the device offers the same delivery as opioid reversal medicine through the nasal mucosa to enable it to enter the bloodstream. neffy has a ‘well-tolerated safety profile’ with nasal irritation and headache the most common reported adverse reactions, the manufacturer states.
 
Allergist Professor Connie Katelaris said the introduction of neffy marks an important step for allergy management.
 
‘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.
 
‘neffy has been available overseas in the US and Europe for some time and we have seen real-world experience ... it’s great to see [it] will now be available in Australia.’
 
The new treatment for anaphylaxis comes as nasal sprays offering needle-free alternatives for various conditions are emerging.
 
Sprays for influenza vaccination are rolling out across Australia, as well as other research demonstrating the benefits of nasal sprays for sleep apnoea and depression. A nasal spray option for naloxone to reverse or reduce the effects of opioid overdose is also available nationwide.
 
According to the Australian Commission on Safety and Quality in Health Care, a 51% increase in hospital emergency department presentations and a 35% increase in hospitalisations due to anaphylaxis were reported between 2015 and 2020.
 
The Australasian Society of Clinical Immunology and Allergy (ASCIA) is updating its guidelines and training resources to better support healthcare professionals as the ‘anaphylaxis treatment landscape evolves’, says ASCIA Anaphylaxis Committee Chair Associate Professor Kristina Rueter.
 
‘ASCIA welcomes the introduction of new treatment options for clinicians and patients. 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.
 
Introduction of the nasal spray is expected to bring significant change in anaphylaxis management by expanding choice for patients as gaps remain in confidence and competence of administering injectable adrenaline such as EpiPen.
 
It is expected to be available from February as a Schedule 4 medicine via private prescription, with an application for a PBS listing submitted and consideration scheduled for March.
 
GP and CSL Seqirus Executive Medical Director Dr Jonathan Anderson says expanding access to anaphylaxis treatment options is a priority.
 
‘[We are] proud to add this innovation to the toolkit of Australian healthcare professionals as they support patients in accessing a treatment that is right for them,’ he said.
 
‘The registration ... is just the first step. We are looking forward to working together with healthcare professionals, the community and government to ensure more Australians can access neffy.’
 
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