Valdoxan® (Agomelatine): new Evidence Shows Significant Efficacy in Treatment of Anxiety in Depressed Patients

Paris (ots/PRNewswire) -

- Positive Correlation Established Between Valdoxan's Efficacy
and Disease Severity

New data, presented today at the 24th European College of
Neuropsychopharmacology (ECNP) Congress, further highlight the
distinctive profile of efficacy of Valdoxan(R) (agomelatine) in the
treatment of anxiety in depressed patients when compared with other
commonly prescribed antidepressants. Additionally, Valdoxan's
anxiolytic efficacy was even stronger in depressed patients with
severe anxiety symptoms.

Today's new data relates to an analysis of six large multicenter
studies, each with a duration between 6 and 8 weeks, involving a
total population of almost 2,000 patients with major depressive
disorder (MDD). Among these, more than 900 patients were classified
as severely anxious, defined by a score of at least 5 points on the
anxiety subscale of the Hamilton Depression Rating Scale (HAM-D).

Three of the six studies compared Valdoxan to the selective
serotonin reuptake inhibitors (SSRIs) sertraline and fluoxetine, and
the serotonin noradrenalin reuptake inhibitor (SNRI) venlafaxine,
while the other three studies compared Valdoxan to placebo.

"These new data are important, because anxiety within depression
is common and associated with worse prognosis, increased disability
and higher use of medication", explained Prof. Dan Stein, Professor
and Chair of the Dept. of Psychiatry and Mental Health at the
University of Cape Town, South Africa. "This new evidence establishes
the novel antidepressant agomelatine as a promising treatment option
for the management of anxiety in patients suffering from depression."

In comparison to placebo, Valdoxan was found to significantly
reduce anxiety scores on the HAM-D anxiety subscore as early as the
second week (p<0.004). This rapid improvement resulted in a
significant efficacy over the course of the study (p<0.001), which
was even greater in the more anxious patients (p<0.001).

Valdoxan was shown to be more effective in reducing symptoms of
anxiety than its comparators. Valdoxan led to a significant
difference on the Hamilton Anxiety Rating Scale (HAM-A) of 1.39
points (p=0.006). The beneficial effects of Valdoxan compared to the
most commonly prescribed antidepressants was even more pronounced in
the highly anxious depressed patients, with a difference of 1.72
recorded on the HAM-A Scale (p=0.032).

Prof. Sidney Kennedy, Professor of Psychiatry at the University
of Toronto, Canada, highlighted: "In addition to the strong existing
evidence of its antidepressant efficacy, these new data reinforce
agomelatine's powerful efficacy for the management of anxiety versus
other commonly used antidepressants. In addition, this efficacy is
seen in clinical settings with patients reporting 'feeling better'
and being 'less anxious' as early as the second week of treatment.[i,
ii]"

Valdoxan is the first antidepressant that simultaneously acts as
a MT1 and MT2 melatonergic receptors agonist and a 5-HT2C antagonist.
As a result, the antidepressant resynchronises circadian rhythms that
are profoundly disrupted in depressed patients, therefore offering a
totally innovative approach to depression treatment.[i, ii]

Valdoxan is the first antidepressant with a non-monoaminergic
component[1]. That is why Valdoxan is able to go further providing
clinicians with a greater efficacy, both in reducing depression
symptoms and anxiety symptoms in depressed patients, including those
suffering from marked anxiety symptoms[i].

Valdoxan received EU marketing authorisation in February 2009 and
is now available for the treatment of adult patients with MDD on all
continents, in more than 40 countries worldwide.

Notes to editors

Valdoxan(R) international development programme

The efficacy of Valdoxan in major depressive disorder (MDD) has
been shown in several clinical trials within the international
development programme. This programme which involved almost 6 000
depressed patients documented the unique clinical signature and the
distinctive profile of efficacy of Valdoxan as compared with placebo,
SSRIs and SNRI treatments.

Results of the studies demonstrated that Valdoxan:

- Is more efficacious than conventional antidepressants at
every step of depression treatment, showing greater patient improvement
from the first week of treatment, and whatever the intensity of
depressive symptoms even in the more severely depressed patients[ii,iii
,iv].
- Significantly reduces the incidence of relapse in depressive
patients over the long-term[vi]
- Preserves sexual functioning, is weight neutral and offers a
favourable tolerability profile, thus contributing to a better adherence
and remission in depressed patients[ii,iii]
- Is easy to use: one 25 mg tablet taken at bedtime, without
discontinuation symptoms at the end of treatment[ii,iii]

References
[1] De Bodinat C, et al. Agomelatine, the first melatonergic
antidepressant: discovery, characterization and development. Nature
Reviews. Drug Discovery 2010; 9:628-642
[i] Leproult R, Van Ondergergen A, L'Hermite-Balériaux M et
al.Phase-shifts of 24-h hormonal release and body temperature following
early evening administration of the melatonin agonist agomelatine in
healthy older men. Clin. Endocrinol. 2005;63:298-304
[ii] Hale A, Corral R, Mencacci O, Saiz Ruiz J, Severo A, Gentil V.
Superior efficacy of agomelatine vs fluoxetine in severe MDD patients: a
randomised, double-blind study. J. Eur. College of Neuropsychopharmacol.
2009;19(suppl 3):S418
[iii] Leproult R, Van Ondergergen A, L'Hermite-Balériaux M, Van Cautert
E, Copinschi G. Clin. Endocrinol. 2005;63:298-304
[iv] Hale A, Corral R, Mencacci O, Saiz Ruiz J, Severo A, Gentil V.
Superior efficacy of agomelatine vs fluoxetine in severe MDD patients: a
randomised, double-blind study. J. Eur. College of Neuropsychopharmacol.
2009;19(suppl 3):S418
[v] De Bodinat C, et al. Agomelatine , the first melatonergic
antidepressant : discovery, characterization and development. Nature
Reviews. Drug Discovery 2010; 9:628-642
[vi] Goodwin G et al, Agomelatine Prevents Relapse in Patients with Major
Depressive Disorder Without Evidence of a Discontinuation Syndrome: A
24-Week Randomized, Double-Blind, Placebo-Controlled Trial. J. Clin.
Psychiatry. 2009;70(8):1128-1137
[vii] Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine
in the Treatment of Major Depressive Disorder: An 8-Week, Multicenter,
Randomized, Placebo-Controlled Trial J. Clin. Psychiatry.
2010;71(5):616-626
[viii] Kasper S et al. Efficacy of the Novel Antidepressant Agomelatine
on the Circadian Rest-Activity Cycle and Depressive and Anxiety Symptoms
in Patients with Major Depressive Disorder: A Randomized, Double-Blind
Comparison with Sertraline. J. Clin. Psychiatry. 2010;71(2):109-120
[ix] Kennedy S, Rizvi S. Agomelatine in the treatment of major depressive
disorder: potential for clinical effectiveness. CNS Drugs 2010 Review
Article
[x] Kennedy SH, Rizvi S, Fulton K, Rasmussen J. A Double-Blind Comparison
of Sexual Functioning, Antidepressant Efficacy, and Tolerability Between
Agomelatine and Venlafaxine XR. J Clin Psychopharmacol. 2008;28:329-333
[xi] Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I.
Absence of discontinuation symptoms with agomelatine and occurrence of
discontinuation symptoms with paroxetine: a randomized, double-blind,
placebo-controlled discontinuation study. Int Clin Psychopharmacol.
2004;19:271-280
[xii] Valdoxan(R) Summary of Product Characteristics

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