Valdoxan(R), the First Melatonergic Antidepressant, Confirms its Efficacy in Preventing Relapse Whatever the Severity of the Depression

    VIENNA, Austria, Oct. 15 /CNW/ - Valdoxan(R) (agomelatine), the first
melatonergic antidepressant, is an effective, long-term treatment for Major
Depressive Disorder (MDD) according to new data presented today at the
European College of Neurospsychopharmacology (ECNP) annual congress. The new
international study showed Valdoxan's efficacy in preventing relapse in
out-patients with MDD over six-months, irrespective of the severity of
    "The short term efficacy of this novel antidepressant has already been
demonstrated in several clinical studies", points out study investigator
Professor Guy Goodwin from the Department of Psychiatry, University of Oxford,
UK. "This new study demonstrated the long-term efficacy of Valdoxan in the
prevention of depressive relapses, after an initial response to the drug, over
a treatment period of six months. The results show that Valdoxan is a
promising therapeutic agent for the short-and-long-term management of MDD,
which offers remission to our depressed patients with very few adverse
    The multicentre, randomised, double-blind study involved nearly 500
(n=492) patients with recurrent MDD according to the DSM-IV classification.
The primary outcome of the study was time to relapse (relapse defined as
HAM-D17 score(3) 16 or any withdrawal for lack of efficacy according to the
investigator's opinion during the randomised period).

    Valdoxan: significantly lower relapse rate

    Overall, Valdoxan was associated with a significantly lower relapse rate
compared to placebo (p=0.0001). Nearly half of all patients who received
placebo relapsed (46.6%) compared to just over fifth of patients who received
Valdoxan (21.7%) over a six month treatment period, representing a 54%
reduction of the risk of relapse for patients treated with Valdoxan. These
results demonstrating the long-term antidepressant efficacy of Valdoxan were
further confirmed in the more severely depressed subpopulation of the study.
In patients with a baseline HAM-D17 score of greater than or equal to 25,
Valdoxan was associated with a significantly fewer cumulative relapses (22.7%)
than placebo (50.4%) over six months. Interestingly, the low number of early
relapses (up to 6-8 weeks after randomisation) reported by patients switched
from Valdoxan to placebo is an additional proof of absence of discontinuation
symptoms when stopping Valdoxan treatment.
    Valdoxan treatment was found to be well tolerated with the rate of
treatment-emergent adverse events similar in patients receiving active
treatment and placebo.

    Valdoxan: efficacy in severely depressed patients

    The antidepressant properties of Valdoxan have been demonstrated in
several clinical trials, including large-scale phase III studies either versus
placebo or other antidepressants(2-6). Efficacy has been shown to be superior
in comparison to placebo and at least equal in comparison to selective
serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake
inhibitors (SNRIs), against which Valdoxan showed favorable trends in terms of
response and remission rates. Valdoxan also demonstrated to be effective
across clinical trials, whatever the severity of depression including in the
subgroup of severely depressed patients. Results of placebo controlled studies
showed that the greater the severity of depression, the greater the treatment
efficacy of Valdoxan.
    A reduction in sleep disruption, a core symptom of depression and a
common problem in people with depression, without any sedation during the
daytime, is one of the clinical benefits of Valdoxan treatment(5,7).

    An innovative approach to the treatment of depression

    Binding studies have shown that Valdoxan, the first melatonergic
antidepressant, interacts with both melatonergic (agonist) receptors (MT1 and
MT2), and with 5-HT2C (antagonist) receptors.(8) The antidepressant efficacy
of Valdoxan involves joint actions on these receptors, possibly interacting
synergistically. Valdoxan resynchronizes altered circadian rhythms of
depressed patients, thus retaining antidepressant efficacy without the typical
side effects such as sexual dysfunction(8,9) and drug discontinuation symptoms
commonly seen with other antidepressants (SSRIs and SNRIs). Overall, Valdoxan
possesses a pharmacological profile entirely distinct from SNRIs and SSRIs,
making it an innovation and a significant advance in the treatment of
    Valdoxan was discovered and developed by Servier, France's leading
independent pharmaceutical company. Novartis acquired exclusive rights to
further develop and market agomelatine in the United States and several other
countries. Servier retained the rights to develop and market the product in
the rest of the world.


    (1) G Goodwin, F Rouillon, R Emsley. Long-term efficacy of agomelatine, a
    novel antidepressant, in the prevention of relapse in out-patients with
    Major Depressive Disorder. ECNP presentation 2007

    (2) Lôo H, Hale A & D'Haenen H. Determination of the dose of agomelatine,
    a melatoninergic agonist and selective 5-HT(2C) antagonist, in the
    treatment of major depressive disorder: a placebo-controlled dose range
    study. Int Clin Psychopharmacol 2002; 17: 239-247.

    (3) Kennedy SH, Emsley RA. Placebo-controlled trial of agomelatine in the
    treatment of major depressive disorder. Eur Neuropsychopharmacol 2006;16:

    (4) Olie J-P, and Kasper Efficacy of agomelatine, a MT1/MT2 receptor
    agonist with 5-HT2C antagonistic properties, in major depressive
    disorder. Int J Neuropsychopharmacol 2007 E-pub ahead of print

    (5) Lemoine P, Guilleminault C and Alvarez E Improvement of subjective
    sleep in Major depressive disorder with a novel antidepressant
    agomelatine: randomized, double blind comparison with venlafaxine. J Clin
    Psychiatry. In Press

    (6) S.H.Kennedy, C. Guilleminault. Antidepressant efficacy of agomelatine
    25-50 mg versus venlafaxine 75-150 mg: two randomized, double blind
    studies. Eur Neuropsychopharmacol 2006, 16, S 319

    (7) MA Quera-Salva, Vanier B, Laredo J, Chapotot F, Moulin C, Lofaso F
    and Guilleminault C. Major Depressive Disorder, Sleep EEG and
    Agomelatine: an open label study. Int J Neuropsychopharmacol 2007, Epub
    ahead of print

    (8) M. Hamon, MJ Millan. Agomelatine, a novel pharmacological approach to
    treating depression. European College of Neuropsychopharmacology (ECNP)
    2006. Eur Neuropsychopharmacol 2006, 16, S 337

    (9) S.H. Kennedy. Favorable sexual profile of agomelatine in depressed
    patients Eur Neuropsychopharmacol 2006, 16, S 319

For further information:

For further information: Moira Gitsham, Tonic Life Communications,
+33-5-46-00-08-20,; Leah Baldwin, Tonic Life
Communications, +44-207-798-9923,

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