Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis).
According to the European Academy of Allergy and Clinical Immunology (EAACI), allergy is the most widespread chronic disorder in Europe, with 150 million Europeans affected in 2015. Around 20% of people suffering from severe allergic conditions live in fear every day of an anaphylactic shock or of dying from an allergic reaction. Anaphylaxis is the most severe form of allergic reaction that can occur within minutes of exposure to an allergen, most often from food, medication or insect stings. It is almost always unexpected and can be life threatening. Delay in clinical diagnosis and treatment can result in airway obstruction or cardiovascular collapse, which can turn fatal.
Treatment with epinephrine, also known as adrenaline, decreases the anaphylactic reaction. Adrenaline binds to a specific type of receptors, known as adrenergic receptors, and lessens the widening of blood vessels and blood vessel permeability induced by histamine (a substance in the body that causes allergic symptoms) during anaphylaxis. Adrenaline also relaxes the smooth muscles in the lungs. Administration of adrenaline during an anaphylactic reaction leads to better blood flow and improved breathing. While epinephrine autoinjectors have been shown to be highly effective when properly used, some patients and caregivers delay or don’t administer treatment in an emergency situation due to fear of the needle, lack of portability or fear of people without medical training to give an injection, among others. The adrenaline nasal spray is absorbed rapidly by the nasal mucosa and distributed through the body.
For ethical and practical reasons, it was not feasible to conduct controlled clinical trials on Eurneffy’s effectiveness in people experiencing a severe allergic reaction, but there is extensive information available about the use of adrenaline to treat severe allergy and it is currently the standard treatment for anaphylaxis. The efficacy and safety of Eurneffy were evaluated in 537 healthy people aged 19 to 55 years old enrolled in fourteen clinical studies. These trials compared Eurneffy with medicinal products where the adrenaline was injected intramuscularly, and looked at the blood pressure and heart rate (pharmacodynamics), as well as at how the medicine is absorbed, modified and removed from the body (pharmacokinetics). The results demonstrate that the effects in the body of nasally-administered adrenaline are comparable to products given by an intramuscular injection. No significant adverse events have been reported in clinical studies with Eurneffy. The most common adverse events 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 recommended additional risk minimization measures to reduce and prevent the potential risk of an inappropriate use of the device. These include training videos and other digital educational materials for patients, carers and healthcare professionals. A training demonstration device of Eurneffy will also be available for these groups of people to simulate correct handling of the device. The opinion adopted by the CHMP is an intermediary step on Eurneffy’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once the marketing authorization has been granted, decisions about price and reimbursement will take place at the level of each Member State, considering the potential role/use of this medicine in the context of the national health system of that country.
Learn more at: First nasal adrenaline spray for emergency treatment against allergic reactions | European Medicines Agency (europa.eu)
