Is agomelatine the same as Valdoxan?
Valdoxan contains the active substance agomelatine. How is Valdoxan used? Valdoxan can only be obtained with a prescription and is available as tablets (25 mg).
Why is agomelatine not available in the US?
Agomelatine has been approved in Europe and Australia. However, its development has been discontinued in the United States because phase 3 trials showed negative results, and there was evidence that the drug induced liver toxicity.
Is valdoxan available in USA?
Agomelatine was approved for medical use in Europe in 2009 and Australia in 2010. Its use is not approved in the United States and efforts to get approval were ended in 2011. It was developed by the pharmaceutical company Servier.
Is agomelatine approved by FDA?
Agomelatine was first approved for clinical use in the European Union in 2009,11 where it is marketed under the names Valdoxan™ or Thymanax. Novartis, who purchased the marketing rights from Servier, is currently seeking United States Food and Drug Administration (FDA) approval for the drug in the United States.
Is agomelatine the same as melatonin?
Agomelatine is a synthetic analogue of melatonin. The manufacturers claim that as well as agonising melatonin, it also antagonises the serotonin 5HT2C receptors. Numerous placebo-controlled trials have assessed the efficacy of agomelatine for major depression.
Does agomelatine increase serotonin?
By increasing melatonin activity, agomelatine also directly increases activity of noradrenaline and dopamine. If serotonin activity is increased, this can cause a number of side effects, most of which are linked to one particular target site (5HT2c).
Is agomelatine on the PBS?
Agomelatine is an analogue of melatonin that is sometimes prescribed in the management of depression. It is not listed on the Pharmaceutical Benefits Scheme (PBS) and is only available in Australia as a private prescription.
Why is Valdoxan not on the PBS?
The drug is not subsidised on the PBS and is expensive for patients. Robert Djundjek, medical director of the company that makes Valdoxan, said medical education was necessary as the drug was the first in a new class of antidepressants, which work on targeting disrupted circadian rhythms.
Is agomelatine a strong antidepressant?
It is a melatonergic (MT1 and MT2) agonist and serotonergic (5HT2C) antagonist. Evidence from animal models of depression, complements emerging clinical data. In a dose range of 25–50 mg daily, agomelatine is an effective antidepressant with a very favorable side-effect profile.
Does agomelatine improve sleep?
Agomelatine significantly improves sleep quality when taken at night to mimic the natural rhythm of melatonin release. It is a weak antagonist at 5-HT2C receptors (see the previous discussion of serotonin receptor blockers) and increases noradrenaline and dopamine release in the frontal cortex.
How good is Valdoxan?
Researchers found that Valdoxan reduced anxiety scores in the HAM-D anxiety sub-score as early as the second week (p<0.004) compared to placebo. The fast improvement produced a significant efficacy over the entire study period (p<0.001), which was even higher in more anxious patients (p<0.001).
How long can you take Valdoxan?
You and your doctor should talk about how long you need to take agomelatine. Most people take it for about six months. If your doctor prescribed you agomelatine for depression, you should probably take it for at least six to nine months, otherwise your symptoms can come back.
Is agomelatine approved in the US?
In the United States, Agomelatine is not approved by the Food and Drug Administration, but you can buy it as a dietary supplement. Agomelatine’s working mechanism is not fully understood, but studies suggest that it relieves depression by blocking 5-HT2C receptors on the noradrenergic and dopaminergic pathways.
How does agomelatine work?
Agomelatine has a unique mechanism, which may be part of the reason as to why it was coveted for the United States market. It has been classified as an ” atypical antidepressant ” and works by affecting both melatonin receptors and serotonin receptors.
What is agomelatine (Valdoxan)?
Agomelatine is a structural analog of melatonin 10 and was developed by the European pharmaceutical company Servier Laboratories Ltd (Neuilly-sur-Seine, France). 11 Agomelatine was first approved for clinical use in the European Union in 2009, 11 where it is marketed under the names Valdoxan ™ or Thymanax.
Is agomelatine a 5-HT2C antagonist?
Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd.