2007-10-15

Valdoxan(R), the First Melatonergic Antidepressant, Confirms its Efficacy in Preventing Relapse Whatever the Severity of the Depression


Vienna, Austria (ots/PRNewswire) - Valdoxan(R) (agomelatine), thefirst melatonergic antidepressant, is an effective, long-termtreatment for Major Depressive Disorder (MDD) according to new datapresented today at the European College of Neurospsychopharmacology(ECNP) annual congress. The new international study showed Valdoxan'sefficacy in preventing relapse in out-patients with MDD oversix-months, irrespective of the severity of depression(1).

"The short term efficacy of this novel antidepressant has alreadybeen demonstrated in several clinical studies", points out studyinvestigator Professor Guy Goodwin from the Department of Psychiatry,University of Oxford, UK. "This new study demonstrated the long-termefficacy of Valdoxan in the prevention of depressive relapses, afteran initial response to the drug, over a treatment period of sixmonths. The results show that Valdoxan is a promising therapeuticagent for the short-and-long-term management of MDD, which offersremission to our depressed patients with very few adverse effects".

The multicentre, randomised, double-blind study involved nearly500 (n=492) patients with recurrent MDD according to the DSM-IVclassification. The primary outcome of the study was time to relapse(relapse defined as HAM-D17 score ³ 16 or any withdrawal for lack ofefficacy according to the investigator's opinion during therandomised period).

Valdoxan: significantly lower relapse rate

Overall, Valdoxan was associated with a significantly lowerrelapse rate compared to placebo (p=0.0001). Nearly half of allpatients who received placebo relapsed (46.6%) compared to just overfifth of patients who received Valdoxan (21.7%) over a six monthtreatment period, representing a 54% reduction of the risk of relapsefor patients treated with Valdoxan. These results demonstrating thelong-term antidepressant efficacy of Valdoxan were further confirmedin the more severely depressed subpopulation of the study. Inpatients with a baseline HAM-D17 score of greater than or equal to25, Valdoxan was associated with a significantly fewer cumulativerelapses (22.7%) than placebo (50.4%) over six months.Interestingly, the low number of early relapses (up to 6-8 weeksafter randomisation) reported by patients switched from Valdoxan toplacebo is an additional proof of absence of discontinuationsymptoms when stopping Valdoxan treatment. Valdoxan treatment wasfound to be well tolerated with the rate of treatment-emergentadverse events similar in patients receiving active treatment andplacebo.

Valdoxan: efficacy in severely depressed patients

The antidepressant properties of Valdoxan have been demonstratedin several clinical trials, including large-scale phase III studieseither versus placebo or other antidepressants(2-6). Efficacy hasbeen shown to be superior in comparison to placebo and at least equalin comparison to selective serotonin reuptake inhibitors (SSRIs) andselective noradrenaline reuptake inhibitors (SNRIs), against whichValdoxan showed favorable trends in terms of response and remissionrates. Valdoxan also demonstrated to be effective across clinicaltrials, whatever the severity of depression including in the subgroupof severely depressed patients. Results of placebo controlled studiesshowed that the greater the severity of depression, the greater thetreatment efficacy of Valdoxan.

A reduction in sleep disruption, a core symptom of depression anda common problem in people with depression, without any sedationduring the daytime, is one of the clinical benefits of Valdoxantreatment(5,7).

An innovative approach to the treatment of depression

Binding studies have shown that Valdoxan, the first melatonergicantidepressant, interacts with both melatonergic (agonist) receptors(MT1 and MT2), and with 5-HT2C (antagonist) receptors.8 Theantidepressant efficacy of Valdoxan involves joint actions on thesereceptors, possibly interacting synergistically. Valdoxanresynchronizes altered circadian rhythms of depressed patients, thusretaining antidepressant efficacy without the typical side effectssuch as sexual dysfunction(8,9) and drug discontinuation symptomscommonly seen with other antidepressants (SSRIs and SNRIs). Overall,Valdoxan possesses a pharmacological profile entirely distinct fromSNRIs and SSRIs, making it an innovation and a significant advance inthe treatment of depression.

Valdoxan was discovered and developed by Servier, France's leadingindependent pharmaceutical company. Novartis acquired exclusiverights to further develop and market agomelatine in the United Statesand several other countries. Servier retained the rights to developand market the product in the rest of the world.

References

(1) G Goodwin, F Rouillon, R Emsley. Long-term efficacy ofagomelatine, a novel antidepressant, in the prevention of relapse inout-patients with Major Depressive Disorder. ECNP presentation 2007

(2) Lôo H, Hale A & D'Haenen H. Determination of the dose ofagomelatine, a melatoninergic agonist and selective 5-HT(2C)antagonist, in the treatment of major depressive disorder: aplacebo-controlled dose range study. Int Clin Psychopharmacol 2002;17: 239-247.

(3) Kennedy SH, Emsley RA. Placebo-controlled trial of agomelatinein the treatment of major depressive disorder. EurNeuropsychopharmacol 2006;16: 93-100.

(4) Olie J-P, and Kasper Efficacy of agomelatine, a MT1/MT2receptor agonist with 5-HT2C antagonistic properties, in majordepressive disorder. Int J Neuropsychopharmacol 2007 E-pub ahead ofprint

(5) Lemoine P, Guilleminault C and Alvarez E Improvement ofsubjective sleep in Major depressive disorder with a novelantidepressant agomelatine: randomized, double blind comparison withvenlafaxine. J Clin Psychiatry. In Press

(6) S.H.Kennedy, C. Guilleminault. Antidepressant efficacy ofagomelatine 25-50 mg versus venlafaxine 75-150 mg: two randomized,double blind studies. Eur Neuropsychopharmacol 2006, 16, S 319

(7) MA Quera-Salva, Vanier B, Laredo J, Chapotot F, Moulin C,Lofaso F and Guilleminault C. Major Depressive Disorder, Sleep EEGand Agomelatine: an open label study. Int J Neuropsychopharmacol2007, Epub ahead of print

(8) M. Hamon, MJ Millan. Agomelatine, a novel pharmacologicalapproach to treating depression. European College ofNeuropsychopharmacology (ECNP) 2006. Eur Neuropsychopharmacol 2006,16, S 337

(9) S.H. Kennedy. Favorable sexual profile of agomelatine indepressed patients Eur Neuropsychopharmacol 2006, 16, S 319

ots Originaltext: ServierIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information, please contact: Moira Gitsham, Tonic Life Communications, +33-5-46-00-08-20, moira.gitsham@toniclc.com; Leah Baldwin, Tonic Life Communications, +44-207-798-9923, leah.baldwin@toniclc.com

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Valdoxan(R), the First Melatonergic Antidepressant, Confirms its Efficacy in Preventing Relapse Whatever the Severity of the Depression

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