What is Daxas?
Daxas is a medicine that contains the active substance roflumilast. The medicine is available as yellow D-shaped tablets (500 micrograms).
What is Daxas used for?
Daxas is used in the treatment of chronic obstructive pulmonary disease (COPD) in adults with chronic bronchitis (chronic airway inflammation) and with frequent exacerbations of COPD. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty in inhaling and exhaling air from the lungs.
Daxas is not used alone but in addition to treatment with bronchodilators (medicines that widen the airways of the lungs).
The medicine can only be obtained with a prescription.
How is Daxas used?
The recommended dose of Daxas is one tablet once a day. The tablets should be taken with a little water every day at the same time. Patients may have to take Daxas for several weeks before it starts to take effect.
How does Daxas work?
The active substance in Daxas, roflumilast, belongs to a group of medicines called 'phosphodiesterase type 4 inhibitors (PDE4)'. It blocks the action of the PDE4 enzyme that participates in the inflammatory process that leads to COPD. By blocking the action of PDE4, roflumilast reduces inflammation in the lungs helping to alleviate the patient's symptoms or prevent them from worsening.
What studies have been carried out on Daxas?
The effects of Daxas were first tested in experimental models before being studied in humans.
Daxas has been compared with placebo (a sham treatment) in two main studies involving a total of over 3, 000 adults with severe COPD who had had at least one exacerbation of the disease in the past year. During the study, patients could continue to receive treatment with a bronchodilator. The main measure of effectiveness was the improvement in forced expiratory volume (FEV1) and the reduction in the number of moderate or severe COPD exacerbations during one year of treatment. The FEV1 is the maximum air that a person can breathe out in a second.
What benefit has Daxas shown during the studies?
Daxas was more effective than placebo in the treatment of COPD. At the beginning of the study, the two groups of patients had an FEV1 of about 1 liter (1, 000 ml). After one year, patients taking Daxas had a mean increase of 40 ml while those receiving placebo had a mean reduction of 9 ml. Furthermore, patients taking Daxas had an average of 1.1 moderate or severe exacerbations of the disease, compared to the 1.4 exacerbations of patients taking placebo.
What are the risks associated with Daxas?
The most common side effects of Daxas (seen in 1 - 10 patients in 100) are weight and appetite reduction, insomnia, headache, diarrhea, nausea and abdominal pain (stomach ache). Since patients taking Daxas can lose weight, it is advisable that they regularly check their weight. Your doctor may stop treatment with Daxas if the patient loses too much weight. For the full list of all side effects reported with Daxas, see the Package Leaflet.
Daxas should not be used in people who may be hypersensitive (allergic) to roflumilast or any of the other ingredients. It must not be used in patients with moderate or severe liver problems. Daxas is not recommended for patients with diseases that severely weaken the immune system (the body's natural defenses). Since there have been rare cases of patients taking Daxas who developed suicidal thoughts, the medicine is also not recommended in patients who have suffered from depression with suicidal thoughts.
Why has Daxas been approved?
The CHMP noted that there was a need for new treatments for COPD and that the main studies showed a modest benefit of Daxas in patients with severe COPD. The benefit was evaluated in addition to the effects of the treatments to which the patients were already subjected. After assessing all available data on the effects of the medicine, the Committee determined that the benefits of Daxas outweigh its risks and recommended that it be given marketing authorization.
More information on Daxas
On 5 July 2010, the European Commission issued a marketing authorization for Daxas, valid throughout the European Union, to Nycomed GmbH. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Daxas can be found here. For more information about treatment with Daxas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 05-2010.
