Allergy is the most widespread chronic disorder in Europe, affecting 150 million Europeans in 2015, according to the European Academy of Allergy and Clinical Immunology (EAACI), which also notes that around 20% of people with severe allergic conditions live in daily fear of suffering anaphylactic shock or dying due to an allergic reaction.
Anaphylaxis is the most severe form of allergic reaction and can occur within minutes of exposure to an allergen, usually from foods, medications, or insect stings. It is almost always unexpected and can be life-threatening. Delayed diagnosis and treatment can lead to airway obstruction or cardiovascular collapse, which can be fatal.
Now, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine that can be administered through the nose for the emergency treatment of allergic reactions (anaphylaxis).
Treatment with epinephrine, also known as adrenaline, reduces the anaphylactic reaction. Adrenaline binds to specific receptors known as adrenergic receptors and decreases the dilation of blood vessels and permeability induced by histamine (a substance in the body that causes allergic symptoms) during anaphylaxis. It also relaxes smooth muscles in the lungs, improving blood flow and breathing.
Although epinephrine auto-injectors are highly effective when used correctly, some patients and caregivers delay or avoid their use in emergencies due to fear of needles, lack of portability, or the fear that nonmedically trained people feel about administering an injection. Epinephrine nasal spray is rapidly absorbed by the nasal mucosa and distributed throughout the body.
The safety and efficacy of Eurneffy has been proven in clinical trials
For ethical and practical reasons, it was not possible to conduct controlled clinical trials on the effectiveness of Eurneffy in people experiencing a severe allergic reaction. However, there is a lot of information available on the use of adrenaline to treat severe allergies, and it is the standard treatment for anaphylaxis.
The efficacy and safety of Eurneffy were evaluated in 537 healthy people aged 19 to 55 years in 14 clinical studies. These trials compared Eurneffy with medicinal products where adrenaline was injected intramuscularly, and blood pressure and heart rate (pharmacodynamics) as well as the absorption, modification and elimination of the medicine from the body (pharmacokinetics) were analysed. The results show that the effects of nasally administered adrenaline on the body are comparable to those of products administered by intramuscular injection.
The CHMP’s positive opinion is “great news for patients who suffer from these reactions, for allergists in particular and physicians in general” because anaphylaxis “is life-threatening.”
No significant adverse events have been reported in clinical studies with Eurneffy. The most common side effects were similar to those experienced with injections, such as nausea, headache, throat irritation, and dizziness, but also included discomfort and runny nose.
The CHMP recommended additional measures to minimise risks and prevent inappropriate use of the device, including training videos and other digital educational materials for patients, carers and healthcare professionals. A demonstration device of Eurneffy will also be available to simulate the correct use of the device.
The opinion adopted by the CHMP is an intermediate step on Eurneffy’s path towards access to patients. This opinion will now be sent to the European Commission for a decision on marketing authorisation across the EU. Once marketing authorisation has been granted, decisions on pricing and reimbursement will be taken at the level of each Member State, taking into account the potential use of this medicine in the context of that country’s national health system.
A major breakthrough in the treatment of anaphylaxis
Ignacio Dávila, head of the Allergy Service at the University Hospital of Salamanca, professor at the Faculty of Medicine of the University of Salamanca and president of the Spanish Society of Allergology and Clinical Immunology, who was not involved in the study, explained in statements to SMC Spain that the positive opinion of the CHMP is “great news for patients who suffer these reactions, for allergists in particular and doctors in general” because anaphylaxis “is life-threatening.”
“The basis of nasal administration to achieve a systemic effect is based on the high vascularization of the nasal mucosa, the absence of a first-pass effect in metabolization and the speed of action, to which is added the ease of administration and the fact that it is not an invasive method. Intranasal administration with the idea of achieving an effect on the central nervous system is based on the possibility of achieving direct absorption through the olfactory epithelium, avoiding the blood-brain barrier.”
However, he believes that there are still questions to be answered, since “it is not known how the preparation would behave in the treatment of anaphylaxis in a routine clinical practice situation”, and “it is unknown how the preparation will behave in allergic patients, especially if they suffer from nasal conditions or receive topical nasal treatments that could interfere with absorption; or in obese patients; or in those with nasal polyposis or nasal interventions, among other possible factors that may influence the effectiveness of the treatment”.
According to Victoria Cardona, head of the Allergy Department at the Vall d’Hebron University Hospital (Barcelona) and president of the Anaphylaxis Committee of the Spanish Society of Allergology and Clinical Immunology, who also did not participate in the study: “The appearance of new devices that administer the adrenaline dose by alternative routes such as intranasal nebulization could help to solve these fears. The published studies, despite having been carried out mainly on healthy volunteers and not on patients during a reaction, seem to indicate good absorption of the drug and a correct pharmacological effect. Therefore, it could be a paradigm shift in self-treatment by patients during anaphylactic reactions.”
Source: European Medicines Agency (EMA)
