EMA gives green light to first adrenaline nasal spray against potentially fatal anaphylactic shock in severe allergy sufferersThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended granting a marketing authorisation (MA) in the EU for Eurneffy*, an epinephrine-based medicine. Aalternative to injectable formulations for the emergency treatment of anaphylaxisthe most dangerous form of allergic reaction.
According to the European Academy of Allergy and Clinical Immunology (EAACI) – recalls the EMA – Allergy is the most common chronic disease in Europe, with 150 million people affected in 2015. About 20% of severe allergy sufferers live in fear of fatal anaphylactic shock every day. Anaphylaxis can arise suddenly within a few minutes of exposure to an allergen, most often contained in foods or drugs, or carried by insect bites. Delay in diagnosis and treatment can cause airway obstruction or cardiovascular collapse, up to and including death.
The administration of epinephrine, also known as adrenaline – explains the EU regulatory body – decreases the anaphylactic reaction. This substance binds to specific receptors, called adrenergic, reducing the widening and permeability of blood vessels caused by histamine released during the response to an allergen. Adrenaline also relaxes the smooth muscles of the lungs. The treatment, therefore, improves blood flow and breathing. Although epinephrine autoinjectors have been shown to be highly effective when used correctly, emergency therapy is sometimes delayed or not administered due to several factorsfrom the fear of the needle to poor transportability, to the fear that people without medical training could give the injection. Adrenaline nasal spray offers a ‘plan B’ easier: it is rapidly absorbed by the nasal mucosa, distributing throughout the body.
For ethical and practical reasons – explains the EMA – it was not possible to conduct controlled clinical studies on the efficacy of Eurneffy in people with an ongoing severe allergic reaction, but extensive information is available on the use of adrenaline against severe allergy and the substance is currently the standard treatment for anaphylaxis.
The efficacy and safety of Eurneffy were evaluated on 537 healthy people aged 19 to 55, enrolled in 14 clinical trials. These studies compared Eurneffy with medicines that involved intramuscular injection of epinephrine, looking at blood pressure and heart rate, and how the active substance is absorbed, changed and eliminated from the body. The organic effects of adrenaline given by nasal spray were comparable to those of traditional injections. No significant adverse events were reported for Eurneffy; the most common were similar to those experienced with injections (such as nausea, headache, throat irritation and dizziness), but also included nasal discomfort and a runny nose.
The CHMP also recommended specific measures to avoid the risk of inappropriate use of the spray device, including training videos and other digital educational materials aimed at patients and operators. For these groups, a Eurneffy model will also be available for educational purposes, which allows you to simulate the correct use of the spray.
