Further Evidence of Valdoxan(R) Superior Antidepressant Efficacy in Depressed<br>Patients

ISTANBUL, Turkey, Sept. 15 /CNW/ - Further evidence of the superior antidepressant efficacy of Valdoxan(R)/Thymanax(R) (agomelatine) over conventional selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitor (SNRI) antidepressants was presented today at the Servier satellite symposium on the occasion of the 22nd European College of Neuropsychopharmacology (ECNP) Congress, with educational financial support provided by Servier. The new data demonstrates superior antidepressant efficacy over the SSRI fluoxetine, in severely depressed patients.(1)

This new data, in addition to the results of the international development programme in over 6,000 patients and initial feedback from countries in which it is launched, confirm that Valdoxan(R), the first melatonergic antidepressant, has superior antidepressant efficacy at every step of treatment in all depressed patients. This superior efficacy, combined with a good tolerability profile makes Valdoxan(R) the first line treatment of choice for depression, whatever the severity of disease.

"These results, coupled with the existing robust evidence on the efficacy of Valdoxan(R), show that this new antidepressant offers an important alternative for the treatment of depression, including in its severe forms", says leading depression expert Professor Sidney Kennedy, Psychiatrist-in-Chief of the University Health Network and Professor of Psychiatry, University of Toronto, Canada. "Despite the availability of a wide range of existing antidepressants, there are clear unmet needs in the management of depression. Valdoxan(R), with its innovative mode of action, represents a totally new approach to the management of Major Depressive Disorder and will hopefully offer a brighter future for depressed patients."

New data(1)

The study was designed to demonstrate the superior antidepressant efficacy of agomelatine compared to the SSRI fluoxetine, in severely depressed patients. It was a randomised, multinational, double-blind study carried out in 515 patients presenting with a current severe episode of Major Depressive Disorder (MDD). Depression severity was defined on two standard depression rating scales, the HAM-D17 and CGI-Severity of Illness. To be included in the study, patients had to have a HAM-D17 score greater than or equal to 25 combined with CGI-Severity of Illness score greater than or equal to four.

Patients were split into two groups, receiving either agomelatine 25 mg / 50 mg or fluoxetine 20 mg / 40 mg for an eight-week period (adjustment to the higher dose of each drug was possible after two or four weeks respectively).

Agomelatine antidepressant efficacy was significantly superior to that of fluoxetine (P=0.024), with a difference between treatment in favour of agomelatine at last post-baseline value of 1.49 point on HAM-D17. The superiority of agomelatine compared to fluoxetine was also shown by statistically significant higher percentages of responders on HAM-D17 (defined as a decrease from baseline total score greater than or equal to 50%) over the trial period 71.7% of the patients responded to treatment in the agomelatine group compared to 63.8% in the fluoxetine group (P=0.060). The superiority of agomelatine compared to fluoxetine was again shown on the CGI-Improvement rating scale, a rating scale reflecting clinical judgement and therefore daily clinical practice, with a statistically higher percentage of responders (CGI-I score = 1 or 2; P=0.023) in the agomelatine group (77.7%) than in the fluoxetine group (68.8%).

For those patients, the superior antidepressant efficacy Valdoxan(R) means a unique relief of depressive symptoms, as well as major improvements in their professional, family and social life.

Valdoxan(R) international development programme

The efficacy of Valdoxan(R) in MDD has been shown in several clinical trials within the international development programme. This programme demonstrated the superior efficacy of Valdoxan(R) as compared with placebo, SSRIs and SNRI treatments. Results of the studies showed that:

    
    -   Valdoxan(R) offers superior antidepressant efficacy in all depressed
        patients, whatever the severity of depression(1)

    -   Valdoxan(R) offers superior antidepressant efficacy at every step of
        depression treatment, showing superior patient improvement within the
        first week of treatment, as reported by both physicians and patients
        themselves(2,3)

    -   Valdoxan(R) 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(4)

    -   Valdoxan(R) significantly reduces the incidence of relapse in
        depressive patients over the long term(3)

    -   Valdoxan(R) preserves sexual functioning, is weight neutral and
        offers a favourable tolerability profile, thus resulting in better
        adherence and remission in depressed patients(5)

    -   Valdoxan(R) is easy to use: one 25 mg tablet taken at bedtime,
        without discontinuation symptoms at the end of treatment(6)

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

Valdoxan(R) 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(R) resynchronises circadian rhythms that are profoundly disrupted in depressed patients.(7)

"Valdoxan(R) has the potential to relieve the symptoms of depression with a fast onset of action and reduced risk of significant adverse effects," points out Doctor Philip Gorwood, Professor of Psychiatry at Sainte Anne Hospital, Paris, France. "It has a novel mechanism of action unlike those of the commonly-prescribed antidepressants, the SSRIs and SNRIs, as Valdoxan(R) exerts its antidepressant efficacy without having an impact on serotonin levels".

Valdoxan(R) was discovered and developed by Servier, France's leading independent pharmaceutical company. Valdoxan(R) received EU marketing authorisation in February 2009 and is now available in several countries worldwide for the treatment of adult patients with MDD.

In accordance with point 25.5 of the ECNP congresses and pharmaceutical companies guidelines (October 2008), the above statement does not reflect the opinions of the ECNP.

Servier satellite symposium on the occasion of the 22nd ECNP Congress with educational financial support provided by Servier.

Notes to editors

Major Depressive Disorder (MDD)

Major depressive disorder (MDD) - also known as unipolar depression - is a common and disabling mental health disorder. Globally, MDD is increasing in prevalence, affecting approximately 121 million people worldwide, yet it remains under-diagnosed and under-treated.(8) Overall, around 60 million Europeans currently suffer from some form of depression, with an estimated 33.4 million of them suffering with severe depression.(9) The World Health Organization (WHO) reported that depression was the fourth leading cause of health-related disability, and has estimated that by 2020 depression will rank second only to heart disease as a worldwide cause of disability.

For many patients, depression is a chronic and recurrent illness. Nearly a third of patients with MDD are still depressed after one year, and over 10% remain ill after five years. For those patients who recover from a depressive episode, over a half will suffer a recurrence.(10)

    
    References
    --------------------
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           efficacy of agomelatine vs fluoxetine in severe MDD patients: a
           randomised, double-blind study
    (2).   Kasper S, Laigle L, Baylé F. Eur Neuropsychopharmacol. 2008;18
           (suppl4):S336.Abstract P2c022.
    (3).   Goodwin G, Rouillon F, Emsley R. Eur Neuropsychopharmacol. 2008;18
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    (4).   Lemoine P, Guilleminault C, Alvarez E. J Clin Psychiatry.
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    (5).   Kennedy SH, Rizvi S, Fulton K, Rasmussen J. J Clin
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    (6).   Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I.
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    (7).   Leproult R, Van Ondergergen A, L'Hermite-Balériaux M, Van Cautert
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    (8).
     http://www.who.int/mental_health/management/depression/definition/en/
           (accessed 20 July 2009)
    (9).   WHO Europe, Mental health in the WHO European Region Fact sheet
           EURO/03/03, 8 September 2003
    (10).  Prevalence, burden and diagnosis - Chapter One, Page One, 5 April
           2007
    

For further information: Monica Gounaropoulos, Tonic Life Communications (tel [phone]), [email protected] or Claire Mosley, Tonic Life Communications (tel [phone]), [email protected]