Anaphylactic shock: First adrenaline nasal spray approved

The anaphylactic shock or anaphylaxis It is the most serious form of allergic reaction. It can occur within minutes of exposure to an allergen, most often caused by food, medicines or insect bites. Early intervention is essential since a delay in clinical diagnosis and treatment can prove fatal.

The only one life-saving drug in these cases it is theadrenalineprescribed to people with known and potentially serious allergies, in the form of auto injectors to always carry with you.

Although the adrenaline or epinephrine autoinjectors have proven to be highly effective if used correctly, sometimes emergency therapy is delayed or not administered due to various factorsas the fear of the needle, poor portability but also the fear that people without medical training can administer the injection.

Obstacles that could however be overcome in the future. In fact, the Committee for Medicinal Products for Human Use (CHMP) recently of the EMA recommended to grant Marketing Authorization in the European Union for the first medicine from take nasally, for the treatment of allergic reaction emergency.

According to the European Academy of Allergy and Clinical Immunology (EAACI), allergy is the most common chronic disorder in Europe, with 150 million Europeans affected in 2015. About 20% of people suffer from severe allergic conditions lives every day in fear of one anaphylactic shock or die from an allergic reaction.

In the course of anaphylaxis, in fact, they are released into the body large amounts of histamine and other substances that suddenly and abruptly cause the dilation of blood vesselswith possible consequent lowering of blood pressure And loss of consciousness (Source: Humanitas.it).

How adrenaline works

The epinephrine treatment – explains the EMA- reduces anaphylactic reaction. Adrenaline is in fact linked to one specific type of receptorsknown as receptors adrenergicreducing the widening and permeability in blood vessels caused by histamine released during the response to an allergen. Adrenaline also relaxes the smooth muscles of the lungs. This is why the treatment leads to a better blood flow and better breathing.

There administration of adrenaline through a nasal spray could constitute a valid alternative, from a practical point of view, to the use of autoinjectors, while still guaranteeing efficacy: in fact, through this device Adrenaline is rapidly absorbed by the nasal mucosa And distributed throughout the body.

I study

For ethical and practical reasons, it was not possible conduct clinical trials checked on the effectiveness of the new spray in people who have had a severe allergic reaction – underlines the EMA – but more information is available extensive information on the use of adrenaline to treat severe allergies and is currently the standard treatment for anaphylaxis.

The efficacy and safety of the nasal spray have been evaluated in 537 healthy people aged 19 to 55 years enlisted in fourteen clinical studies. These trials compared the new drug with drugs that involved the intramuscular injection of adrenaline, examining blood pressure and heart rateas well as how the medicine is absorbed, changed and eliminated from the body.

The results show that the effects in the body of adrenaline administered nasally I am comparable to those produced by intramuscular injection.

Furthermore, no adverse reactions have been reported in clinical studies significant adverse events: i most common were similar to those experienced with injectionsas nausea, headache, throat irritation and dizziness, to which were added nasal discomfort and runny nose.

The next steps

To minimise the risks of inappropriate use of the spray device, the CHMP also recommended theadoption of some specific measures such as training videos And digital educational materials for patients and healthcare professionals. For these groups of people there will also be a model of the new device for educational purposeswhich allows you to simulate the correct use of the spray.

The opinion adopted by the CHMP represents a intermediate step in the path of the new drug towards patient access. It is now up to the European Commission to express oneself on theMarketing Authorization at EU level.

SCIENTIFIC SOURCES CITED IN THIS ARTICLE:

• EMA – First nasal adrenaline spray for emergency treatment against allergic reactions
• Anaphylactic shock: symptoms and what to do – Humanitas.it
• ISSalute – Anaphylactic shock or anaphylaxis