Breaking News on Drug Discovery

Melatonergic antidepressant shows favourable efficacy
25/10/2005

The first melatonergic antidepressant to offer a new approach to the treatment of depression is just over the horizon after new data demonstrated positive efficacy with marked improvements in sleep with no effect on daytime vigilance.

Current treatments for depression, suffer from patient acceptability, having an unwelcome reputation of causing unbearable side effects.

Indeed, acceptance of antidepressants of all drug classes is a major concern and is still one of the unmet needs in treating depression.

This approach aims to relieve depressive patients' sleep disruption without affecting daytime vigilance - a key advantage for an antidepressant medicine, as sleep complaints are common and a major disabling feature of depression.

Valdoxan (agomelatine), is the first melatonergic antidepressant acting as a MT1 and MT2 receptor agonist with additional 5-HT2C receptor antagonist properties.

Due to this unique mode of action, it does not show the typical side effects found with SSRIs and SNRIs, in particular sexual dysfunction and drug discontinuation symptoms, two common side-effects that patients find particularly troubling.

Valdoxan has a similar efficacy to the serotonin noradrenergic reuptake inhibitor (SNRI) venlafaxine, but not the often observed side-effects associated with the SNRI.

Data presented at the 18th Congress of the European College of Neuropsychopharmacology (ECNP), showed preliminary results of a specific study, which compared Valdoxan (25 - 50 mg / day) with venlafaxine (75 - 150 mg / day) in depressed patients.

Treatment with Valdoxan, discovered and developed by Servier, resulted in significantly better and earlier improvement in initiating sleep (p<0.001).

A polysomnography study in depressed patients showed that Valdoxan 25 mg had a beneficial effect on sleep patterns.

"In addition to its effective antidepressant properties, Valdoxan is the only antidepressant to have a specific action on circadian rhythms," says Dr Raymond Lam, Department of Psychiatry, University of British Columbia, Canada.

"It can relieve sleep complaints in depressed patients without residual impairment and thus appears to be an innovative, new pharmacological treatment for depression," he added.

The drug is currently in Phase III trials and a registration dossier for an indication in major depressive disorder (MDD) was submitted to the European Regulatory Agency (EMEA) in 2005.

There are many issues with current therapies for these disorders, particularly for depression. Selective Serotonin Reuptake Inhibitors (SSRI) are the current choice.

However, there is a 3-week gap for the drug to take effect. During this period the person becomes anxious for the drug to work and then more depressed because they feel the drug isn't working.

Depression is the single largest CNS drug market with global antidepressant sales of $19.5 billion in 2003. The WHO estimates that about 340 million people suffer from depression worldwide but only 20 per cent of patients with clinical depression receive treatment.

Many patients are underserved by or do not respond to currently available treatments and existing therapies, such as the selective serotonin reuptake inhibitor class, have a number of limitations such as delayed onset of anti-depressant activity and side effects.

Accordingly, there is great demand from physicians and patients for new types of therapies that work via new mechanism of actions and do not share these side effects.

Source: Decision News Media

Wow, I'm really interested in this. I've read everything that would come up on a search about it. It looks like most of the research and drug testing is being done in Europe. Anyone know if anything's being done in the U.S.? I was also wondering about weight gain as a side effect. I couldn't find anything on that. The way things go here it could be a few years till it comes to this country.

Sally

I'm wondering if there has been any updates on whether this is being tested for approval in the US? I contacted the FDA and was told Novartis was "possibly doing testing" however according to the internet it's another company doing it, at least in other countries. There doesn't appear to be any testing being done here that I could find. I would love to be able to change from effexor xr to this drug if it ever gets approval here in the US. The side effects it doesn't have along with the improved sleep are two issues I struggle with along with the depression.
I have been searching on the internet and really don't understand why a drug as promising as this isn't available in our country as well as world-wide. It's sad.

I'm still watching this one too. It still doesn't seem like it's getting too far in the U.S. I think it will blow the other AD's out of the market. Probably going to cost a fortune too. I just wish they'd get on with it.

Sally

agomelatine studies ARE currently underway in the us and are in stage 4... i participated in a year long one.. it is the only ad that has had any positive change and actually helped me
i am eagerly awaiting the fda approval
i live in va and participated in study here
best thing i have ever done
it truly saved my life

I'd love to get my hands on some of that stuff. It is exciting that they seem to be coming up with a new class of ads. This could really, really change things for a lot of people.

PLEASE post if you know anything about this med; ie...it's availability, where it's being studied in US, etc.

I need help now for TRD.

Thank You; eve

I just checked on the web and it is out and called Valdoxan but is only available in Europe right now (since November 08). You can go on wikipedia for more info.

Its in phase 3 in the US. So, hang in there unless you are in Europe than its available there.