Valdoxan(R) Granted Marketing Authorisation for the Treatment of Major Depressive Episodes in Europe

    PARIS, Feb. 24 /CNW/ - The European Commission has granted marketing
authorisation for Servier's Valdoxan(R)/Thymanax(R) (agomelatine), the first
melatonergic antidepressant for the treatment of adult patients with major
depressive episodes.
    "There is still great scope for improved therapies to treat the
devastating effects of depression," said Professor Goodwin from Warneford
Hospital, Oxford, United Kingdom. "Valdoxan is an innovative, new approach to
the management of depression that compares favourably to existing treatments.
It has proven, sustained efficacy across a wide range of depressed patients,
including those who are most severely depressed."
    Valdoxan, one 25 mg tablet taken at bedtime, offers new hope for the 33
million people in Europe suffering from major depressive episode. Valdoxan's
powerful antidepressant efficacy combined with its good safety and
tolerability profile is a result of its unique receptor profile. Valdoxan is
the first antidepressant with melatonin receptor (MT1) and (MT2) agonist
properties and 5-hydroxytryptamine (serotonin) receptor 2C (5-HT2C) antagonist
properties. This unique receptor profile of Valdoxan allows for the first time
the restoration of the circadian rhythms of depressed patients.(1)

    Valdoxan: significant antidepressant efficacy from the start to the end
    of treatment

    The European approval of Valdoxan is based on both short and long-term
results from a large, comprehensive, international development programme
including almost 6,000 adult patients with depression. The results demonstrate
the superior efficacy of Valdoxan as compared with placebo, selective
serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake
inhibitor (SNRI) treatments and also show that:

    -  Valdoxan has proven efficacy whatever the intensity of symptoms, in
       moderately and severely depressed adult patients (18-65 years old)
       presenting a first or recurrent episode of depression(2)

    -  Valdoxan has demonstrated efficacy at every step of depression
       treatment, showing superior clinical improvement within the first week
       of treatment, as reported by both physicians and patients(3),(4)

    -  Valdoxan is effective against all the core symptoms of depression,
       including depressed mood, anxiety, feeling of guilt, psychomotor
       retardation, sleep disturbances, and daytime fatigue, leading
       depressed patients to a more complete and sustained remission(5)

    -  Valdoxan has been proven to significantly reduce the incidence of
       relapse in depressive patients over the long term(4)

    -  Valdoxan preserves sexual functioning, is weight neutral and offers a
       favourable tolerability profile, thus resulting in better adherence
       and remission in depressed patients(6)

    -  Valdoxan is easy to use from beginning to end: a simple dose of one
       25 mg tablet taken orally at bedtime, without discontinuation symptoms
       at the end of treatment.(7)

    "Valdoxan has the potential to relieve the symptoms of depression with a
reduced risk of significant adverse effects," said Professor Goodwin. "With
noticeable clinical improvement as early as the first week of treatment,
Valdoxan represents an advance for depressed patients who today expect a more
complete remission."

    Valdoxan: a major therapeutic advance in management of depression through
    the restoration of circadian rhythms

    Valdoxan is the result of an advanced pharmacological research programme
involving investigation centres all around the world. It is the first
antidepressant that simultaneously acts as a MT1 and MT2 melatonergic
receptors agonist and a 5-HT2C antagonist. As a result, Valdoxan
resynchronises circadian rhythms that are profoundly disrupted in depressed
    "Valdoxan's mechanism of action is unlike those of the commonly-prescribed
antidepressants, the SSRIs and SNRIs, as Valdoxan exerts its antidepressant
efficacy without having an impact on serotonin levels," pointed out Professor
Racagni from the University of Milan, Italy.

    The recommended dose of Valdoxan is one tablet of 25 mg taken once daily,
orally at bedtime.

    Following approval from the European Commission, Valdoxan is expected to
become commercially available in European countries in the coming months.

    Valdoxan(R) was discovered and developed by Servier, France's leading
independent pharmaceutical company.


    (1) LA'o H, Hale A, D'haenen H. Int Clin Psychopharmacol.
    (2) Montgomery SA, Kasper S. Int Clin Psychopharmacol. 2007;22:283-291
    (3) Kasper S, Laigle L, BaylA(C) F. Eur Neuropsychopharmacol.
        2008;18(suppl4):S336.Abstract P2c022.
    (4) Goodwin G, Rouillon F, Emsley R. Eur Neuropsychopharmacol.
        2008;18(suppl4):S338. Abstract P2c025.
    (5) Lemoine P, Guilleminault C, Alvarez E. J Clin Psychiatry.
    (6) Kennedy SH, Rizvi S, Fulton K, Rasmussen J. J Clin Psychopharmacol.
    (7) Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I. Int
        Clin Psychopharmacol. 2004;19:271-280
    (8) Leproult R, Van Ondergergen A, L'Hermite-BalA(C)riaux M, Van Cautert
        E, Copinschi G. Clin Endocrinol. 2005;63:298-304.

For further information:

For further information: Monica Gounaropoulos, Tonic Life
Communications, tel. +44-207-798-9910,; or Claire Mosley,
Tonic Life Communications, tel. +44-207-798-9900,

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