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

Positive correlation established between Valdoxan’s efficacy and disease severity

Paris, 5 September 2011 – New data, presented today at the 24th European College of Neuropsychopharmacology (ECNP) Congress, further highlight the distinctive profile of efficacy of Valdoxan® (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.[iii],[iv]

Valdoxan is the first antidepressant with a non-monoaminergic component[v] . 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 symptomsi.

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.

– 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 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[vi],[vii],[viii]

· Significantly reduces the incidence of relapse in depressive patients over the long-termvi

· Preserves sexual functioning, is weight neutral and offers a favourable tolerability profile, thus contributing to a better adherence and remission in depressed patients[ix],[x]

· Is easy to use: one 25 mg tablet taken at bedtime, without discontinuation symptoms at the end of treatment,[xi],[xii]

For further information, please contact:

Ben Stewart, Tonic Life Communications (Tel +44 20 7798 9900) ben.stewart@toniclc.com

or

Laura Craggs, Tonic Life Communications (Tel +44 20 7798 9900) laura.craggs@toniclc.com

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[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® Summary of Product Characteristics

Posted: September 2011

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