Adrenaline nasal spray against allergies recommended for approval

Adrenaline nasal spray against allergies recommended for approval



Amsterdam – Allergy sufferers will soon be able to treat anaphylactic reactions with a nasal spray containing adrenaline. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a preparation from a Californian manufacturer after the manufacturer was able to prove in pharmacokinetic and dynamic studies that the adrenaline absorbed through the nasal mucosa reaches the bloodstream in sufficient concentrations.

According to the European Academy of Allergy and Clinical Immunology, allergies are the most common chronic disease in Europe. In 2015, 150 million Europeans were affected. Around 20% of people who suffer from severe allergic diseases live in constant fear of an anaphylactic reaction.

For these patients, there are a number of adrenaline preparations that patients can inject into a muscle using an auto-injector when an anaphylactic reaction begins. Carrying out the injection requires a great deal of self-control from the patient and especially from first aiders, which is not necessary with intranasal administration.

To obtain approval for Eurneffy, the manufacturer Ars Pharmaceuticals from San Diego did not have to conduct clinical endpoint studies as is usually the case. Due to the known effect of intramuscular administration, a placebo-controlled study would not have been ethically justifiable.

The CHMP was satisfied with proving that adrenaline enters the bloodstream just as quickly after intranasal administration and has comparable effects on blood pressure and heart rate as an intramuscular injection. The manufacturer carried out 14 studies on this with 537 healthy people aged 19 to 55 years.

According to the EMA, no significant adverse events occurred in the studies. The most common side effects were similar to those of an intramuscular injection and included nausea, headache, throat irritation and dizziness. Specific side effects of intranasal use were limited to an unpleasant feeling in the nose or a runny nose.

The drug is not yet approved in the USA. Last year, the FDA requested another study on pharmacokinetics and dynamics with repeated administration under a nasal allergen challenge. The manufacturer should also ensure that its drug does not contain nitrosamines. According to the manufacturer, this evidence is now available, so approval is expected soon. © rme/

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