New Data Supports Valdoxan?s Unique Clinical Signature

Amsterdam, 31 August 2010 – Valdoxan®/Thymanax® (agomelatine) is more efficacious than both conventional selective serotonin reuptake inhibitor (SSRI) and serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants, according to new data presented today at the 23rd European College of Neuropsychopharmacology (ECNP) Congress.

This new data supports the unique clinical signature of Valdoxan, already documented by a significant and continuous improvement of the patient condition from the first days of treatment, for a true recovery of depression and effective protection against relapse.1,2,3

New data4

The new data is a result of a pooled analysis of four multicentre, international, randomised, double-blind, parallel-group studies involving outpatients with major depressive disorder (MDD). In each of these individual studies, agomelatine demonstrated to offer a distinctive profile of efficacy leading to an improved treatment of depression.

Agomelatine was compared head-to-head with SSRI (sertraline 50-100 mg, escitalopram 10-20 mg or fluoxetine 20-40 mg) and SNRI antidepressants (venlafaxine 75-150 mg) after six to eight weeks of treatment. Efficacy was assessed using the HAM-D17 total score scale. The overall analysis included 643 patients treated with agomelatine and 657 randomised to SSRI/SNRI therapy.

Agomelatine showed significantly greater antidepressant efficacy than SSRI and SNRI comparators in terms of both HAM-D17 improvement and percentage of responders. Over the treatment period, there was a significant 1.37 point difference on the HAM-D17 total score in favour of agomelatine (p<0.001). Agomelatine’s higher efficacy was also evident in the percentage of responders – patients whose depression improved by a ??% decrease in baseline total HAM-D17 score. Overall, 71.75% of patients achieved a response to agomelatine, versus 64.52% of subjects on SSRIs/SNRI – a statistically significant difference in favour of agomelatine (p=0.005).

“This new data adds to the already compelling clinical evidence for Valdoxan’s efficacy in treating major depressive disorder, even in its severe forms,” notes Professor Siegfried Kasper, Department of Psychiatry and Psychotherapy, University Hospital, Vienna, Austria. “Valdoxan’s excellent antidepressant efficacy – coupled with a unique, ‘first-of-a-kind’ mode of action – marks Valdoxan out as an exciting and innovative treatment for depressed patients.”

In patients with severe depression, agomelatine also performed significantly better than SSRI and SNRI comparators. This severe subpopulation included 1013 patients (499 treated with agomelatine and 514 with SSRIs/SNRIs) with a baseline HAM-D17 score ??. Agomelatine’s antidepressant efficacy again proved significantly better than SSRIs/SNRIs as evidenced by a significant difference in HAM-D17 total score in favour of agomelatine (p=0.014) and a significantly higher percentage of patients responding to agomelatine (71.54% versus 65.29%, p=0.005).

A unique adherence to treatment5 Agomelatine’s clinical efficacy is enhanced by greater adherence to treatment, where patients continue to take their medication as prescribed. Adherence is a key factor in deriving maximal therapeutic benefit from antidepressant medication. Greater adherence to agomelatine is supported by results from the new meta analysis which found that significantly less patients on agomelatine (6.3%) withdrew from trials due to treatment-emergent adverse events, compared to SSRIs/SNRI (10.5%) (p=0.0058).

Valdoxan: a major therapeutic advance in management of depression “Although we have a large armoury at our disposal, gaps still exist in modern depression management” says Professor Raymond Lam, Department of Psychiatry, University of British Columbia, Vancouver, Canada. “As the first-ever antidepressant to target melatonergic MT1 and MT2 receptors and 5-HT2C receptor, with no impact on serotonin levels, Valdoxan offers a new approach to tackling this devastating disease.”

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 patients, therefore offering a totally innovative approach to depression treatment.6,7

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

– ENDS –

Notes to editors

Valdoxan® 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 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, whatever the intensity of depressive symptoms1,2,8 * Significantly reduces the incidence of relapse in depressive patients over the long-term1 * Preserves sexual functioning, is weight neutral and offers a favourable tolerability profile, thus contributing to a better adherence and remission in depressed patients5,9 * Is easy to use: one 25 mg tablet taken at bedtime, without discontinuation symptoms at the end of treatment5,10,11

Major depressive disorder (MDD) 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.12 Overall, around 60 million Europeans currently suffer from some form of depression, with an estimated 33.4 million of them suffering with severe depression.13 The 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.14

For further information, please contact: Claire Mosley, Tonic Life Communications (Tel +44 20 7798 9926) claire.mosley@toniclc.com

References

1. 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 2. 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 3. Lemoine P, Guilleminault C, Alvarez E. Improvement in Subjective Sleep in Major Depressive Disorder With a Novel Antidepressant, Agomelatine: Randomized, Double-Blind Comparison With Venlafaxine. J. Clin. Psychiatry. 2007;68:1723-1732 4. Kasper S, Hale A, Lemoine P, Quera Salva MA. Superior efficacy results of agomelatine in pooled analysis versus SSRI/SNRI. Abstract ECNP 2010 5. Kennedy S, Rizvi S. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs 2010 Review Article. 6. Leproult R, Van Ondergergen A, L’Hermite-Balériaux M, Van Cautert E, Copinschi G. Clin. Endocrinol. 2005;63:298-304 7. 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 8. 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 9. 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. 10. 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 11. Valdoxan® Summary of Product Characteristics 12. http://www.who.int/mental_health/management/depression/definition/en/ (accessed 22 July 2010 13. WHO Europe, Mental health in the WHO European Region Fact sheet EURO/03/03, 8 September 2003 14. Prevalence, burden and diagnosis – Chapter One, Page One, 5 April 2007

 

________________________________ ---- Claire Mosley Account Manager Claire.Mosley@toniclc.com | +44 (0)20 7798 9926 |

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Posted: August 2010

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