Is agomelatine available on the NHS?

Is agomelatine available on the NHS?

Both NICE and the SMC have not approved the use of agomelatine in the NHS.

Why is agomelatine not approved in 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 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.

What is agomelatine used for NHS?

Agomelatine is a new first-in-class antidepressant with a novel mode of action at melatonin and serotonin receptors. It is licensed for the treatment of major depressive episodes with minimum treatment duration of 24 weeks at a standard dose of 25 mg daily, or a higher dose of 50 mg daily.

When is agomelatine prescribed?

If you are 18 or over, your doctor can prescribe you agomelatine as a licensed medicine for depression. Agomelatine isn’t recommended for young people under 18, as no studies have been done for this age group.

Is agomelatine good for anxiety?

Based on the studies that have been done, agomelatine is an efficacious and tolerable antidepressant that is considered beneficial in the management of anxiety. In addition, evidence shows that agomelatine may be more effective in comparison to other antidepressants in patients with severe baseline anxiety.

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).

What are the side effects of agomelatine?

Common side effects, which affect up to one in ten people, include:

• anxiety.
• nausea and vomiting.
• stomach pain.
• abnormal dreams.
• insomnia.
• dizziness.
• drowsiness and fatigue.
• increase in weight.

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 quickly does Valdoxan work?

Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment. Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.

Is Valdoxan a strong antidepressant?

The active substance in Valdoxan, agomelatine, is an antidepressant. It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain. This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.

Is Valdoxan good for sleep?

VALDOXAN can help regulate your ‘body clock’ (circadian rhythm) with positive benefits on mood and sleep in depression.

Is VALDOXAN bad for your liver?

Liver problems have been reported in patients taking Valdoxan/Thymanax (agomelatine), used to treat major depression. To minimise the risk of liver damage, patients should be aware of the following: Before and regularly during treatment with Valdoxan/Thymanax, your doctor will check that your liver is working properly.

What happens if you stop taking VALDOXAN?

Increases in liver enzymes, and rarely inflammation of the liver, have been observed in some patients treated with VALDOXAN. When VALDOXAN was discontinued in these patients, the increases in liver enzymes usually returned to normal levels. This is why your doctor has asked you to have routine blood tests.

How quickly does VALDOXAN work?

Can I stop valdoxan suddenly?

Never stop taking agomelatine suddenly, as this may cause the low mood or depression to return.