What is Thymanax?
Thymanax is a medicine that contains the active substance agomelatine and is available as an orange-yellow, elongated tablet (25 mg).
What is Thymanax used for?
Thymanax is used to treat major depression in adults. Major depression is a disease that causes sufferers mood disorders that interfere with daily life. Symptoms often include profound sadness, a sense of worthlessness, loss of interest in favorite activities, sleep disturbances, a sense of slowing down, feelings of anxiety and changes in weight.
The medicine can only be obtained with a prescription.
How is Thymanax used?
The recommended dose of Thymanax is one tablet a day, taken before going to bed, with or without food. If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together before going to bed. Depressed patients should be treated for at least six months to ensure the disappearance of symptoms.
The patient's liver should be monitored by performing a blood test at the start of treatment and then after about 6, 12 and 24 weeks. Liver checks should also be performed in case of symptoms that could indicate the onset of liver problems. Treatment should be discontinued if abnormal levels of liver enzymes emerge from blood tests. In this case the blood test should be repeated until these levels have returned to normal.
As a positive effect of Thymanax in patients over 65 years has not been clearly demonstrated, the medicine should be used with caution in patients of this age group. It should also be used with caution in patients with severe or moderate kidney problems. The medicine should not be used in patients with liver problems.
How does Thymanax work?
The active substance in Thymanax, the agomelatine, is an antidepressant and acts in two ways: by stimulating the MT1 and MT2 receptors, usually activated by melatonin, and by blocking the 5-HT2C receptors, usually activated by the 5-hydroxytryptamine neurotransmitter (known also as "serotonin"). This is thought to lead to increased levels of dopamine and norepinephrine in nerve cells in areas of the brain involved in mood control. This is believed to help alleviate the symptoms of depression. Thymanax could also be used to normalize the patient's sleep phases.
What studies have been performed on Thymanax?
The effects of Thymanax were first tested in experimental models before being studied in humans.
Thymanax was compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1893 adults with major depression. Three of the studies included patients treated with other antidepressants, fluoxetine or paroxetine, as an 'active comparator'. The active comparator groups were included to check the study's ability to measure the effectiveness of medicines in treating depression. The main efficacy parameter of all five studies was the change in symptoms after six weeks, measured by a standard depression scale, the Hamilton Depression Rating Scale (or HAM-D, Hamilton's depression rating scale) . The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant).
Two other main studies compared the ability of Thymanax and placebo to prevent the recurrence of symptoms in 706 patients with depression previously controlled with Thymanax. The main efficacy parameter was the number of patients with reappearance of symptoms in the 24-26 weeks of treatment.
What benefit has Thymanax shown during the studies?
In short-term studies, Thymanax was more effective than placebo in the two studies where no active comparator was used. In the other three studies, in which an active comparator was used, there were no differences in scores between patients treated with Thymanax and those treated with placebo. However, in two of these studies, no effects of fluoxetine or paroxetine were observed, making it difficult to interpret the results. The additional study indicated that agomelatine was more effective than sertraline, with a HAM-D score difference of 1.68 after six weeks.
In the first of the long-term studies, there was no difference between Thymanax and placebo in preventing the recurrence of symptoms during the 26 weeks of treatment. However, the second study showed that the symptoms reappeared in 21% of patients treated with Thymanax over the course of 24 weeks (34 of 165), compared with 41% of patients treated with placebo (72 of 174).
What is the risk associated with Thymanax?
The most common side effects of Thymanax (seen in between 1 and 10 patients in 100) are headache, dizziness, drowsiness, insomnia, migraine, nausea, diarrhea, constipation, pain in the upper abdomen (stomach ache), hyperhidrosis (excessive sweating), back pain, fatigue, increased liver enzymes and anxiety. Most of the side effects were mild or moderate and occurred within the first two weeks of treatment. Some of them may be related to the patient's depression rather than to Thymanax itself. For the full list of all side effects reported with Thymanax, see the Package Leaflet.
Thymanax should not be used in patients who may be hypersensitive (allergic) to agomelatine or any of the other ingredients. Thymanax should not be used in patients with liver problems, such as cirrhosis (scar formation in the liver) or active liver disease. It must also not be used in patients taking medicines that slow the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Thymanax should also not be used in elderly patients with dementia.
Why has Thymanax been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the benefits of Thymanax in treating depression could be lower than those seen with other antidepressants. However, considering that the medicine is characterized by a new mode of action, a limited number of side effects and a different safety profile compared to existing antidepressants, the committee concluded that Thymanax could be a valid treatment for some patients, on the condition of often checking liver function. The CHMP therefore decided that the benefits of Thymanax outweigh its risks in the treatment of major depressive episodes
in adults. The committee has recommended the granting of the marketing authorization for Thymanax.
What measures are being taken to ensure the safe use of Thymanax?
At the time of marketing of Thymanax, the company that produces it will provide training materials for those who prescribe it. These materials will illustrate the safety of the medicine, in particular the possible effects on the liver and interactions with other medicines.
More information on Thymanax:
On 19 February 2009, the European Commission granted a marketing authorization valid for Thymanax, valid throughout the European Union, to Servier (Ireland) Industries Ltd.
For the full EPAR version of Thymanax, click here.
Last update of this summary: 12-2008.
