The European Medicine Agency’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the EU 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: around 20% of people suffering from severe allergic conditions live in daily fear of an anaphylactic shock or of dying from an allergic reaction.
Anaphylaxis 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 receptor – adrenergic receptors – and lessens the widening of blood vessels and blood vessel permeability induced by histamine (the 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 auto-injectors 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 – by people without medical training – of giving an injection, among other reasons.
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 (from Ars Pharmaceuticals) were evaluated in 537 healthy people aged 19 to 55 enrolled in 14 clinical studies. These 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 minimisation 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 authorisation.
Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each member state, taking into account the potential role/use of this medicine in the context of the national health system of that country.
The product is also expected to launch in the United States shortly, under the name Neffy, after a delay last year when the US Food and Drug Administration (FDA) had requested a pharmacokinetic (PK)/pharmacodynamic (PD) study from the drugmaker that would compare repeat doses of Neffy to an intramuscular epinephrine injection in allergen-induced allergic rhinitis conditions (nasal congestion), before approving it as treatment for Type 1 allergic reactions.
The decision was a complete turnaround from the FDA’s earlier communication that the repeat dose study was to be conducted as part of post-market surveillance.
See more from MedicalBrief archives:
Needle-free anaphylaxis drug thwarted by FDA
FDA fast tracks Epinephrine nasal spray for anaphylaxis