Trydonis
Authorised
This medicine is authorised for use in the European Union
beclometasone / formoterol / glycopyrronium bromide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Trydonis is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Trydonis is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
This medicine is the same as Trimbow, which is already authorised in the EU. The company that makes Trimbow has agreed that its scientific data can be used for Trydonis (‘informed consent’).
Trydonis contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Trydonis is available as a liquid in a portable inhaler device. The recommended dose is two inhalations twice a day.
Patients should be shown how to use the inhaler correctly by a doctor or another healthcare professional, who should also regularly check that the patient’s inhalation technique is correct.
The medicine can only be obtained with a prescription. For more information about using Trydonis, see the package leaflet or contact your doctor or pharmacist.
The three active substances in Trydonis work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Beclometasone belongs to anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system. This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. It opens the airways by blocking muscarinic receptors in muscle cells in the lungs. Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Trydonis has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
In the first study lasting a year, after 26 weeks of treatment, Trydonis improved patients’ FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose. By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trydonis (beclometasone plus formoterol).
In the second study lasting a year, patients treated with Trydonis had 20% fewer exacerbations (flare-ups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist). In this study, Trydonis was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
In the third study lasting a year, patients treated with Trydonis had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Side effects with Trydonis include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
For the full list of side effects and restrictions with Trydonis, see the package leaflet.
Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD. No major safety concerns have been reported with Trydonis, with side effects being manageable and similar to other COPD medicines. The European Medicines Agency therefore decided that Trydonis’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trydonis have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Trydonis is continuously monitored. Side effects reported with Trydonis are carefully evaluated and any necessary action taken to protect patients.
Trydonis received a marketing authorisation valid throughout the EU on 26 April 2018.
Product information
Latest procedure affecting product information:
WS2763/G
13/02/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Trydonis
- Active substance
- Beclometasone dipropionate
- formoterol fumarate dihydrate
- glycopyrronium
- International non-proprietary name (INN) or common name
- beclometasone
- formoterol
- glycopyrronium bromide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AL09
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
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