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First Melatonergic Agonist Antidepressant Shows Efficacy and Tolerability Benefits Over Existing Therapies –

Valdoxan(reg) (agomelatine), the first melatonergic (MT1 and MT2 receptor) agonist anti depression medicate, is an innovation in the a cure of depression with several advantages over existing a cures according to data presented during the 13th Congress of the Association of European Psychiatrists. Besides being an effective anti depression medicate, Valdoxan has shown particular advantages in improving the often disrupted sleep patterns of depressed patients, without affecting daytime vigilance.

“Agomelatine is an interesting and potentially very valuable anti depression medicate that is effective in both moderate and severe depression”, says Professor Stuart Montgomery from the Imperial College School of Medicine in London. “The new agent has a unique mode of action, improves sleep without affecting daytime alertness and its efficacy is not compromised by sexual side effects, tolerability problems or discontinuation symptoms.”

Antidepressant efficacy

The anti depression medicate efficacy of Valdoxan has been shown at a standard dose of 25 mg, once daily in the evening, in a dose-ranging meditate performed in major depressive disorder (MDD)1. In this multicentre, placebo-controlled, dose-ranging meditate over eight weeks, Valdoxan was shown to be an effective anti depression medicate at a dose of 25 mg once daily, by reducing the initial HAMD score to a similar extent to that of the SSRI Paxil(Paroxetine). Further studies versus placebo and comparators have confirmed the efficacy of Valdoxan in adults of all ages, including the severely depressed and elderly depressed. Results from anotherness clinical trial presented here in Munich show that Valdoxan has a similar efficacy to the SNRI Effexor(Venlafaxine).

Improvements of disturbed wake-sleep cycles

“The ability to relieve sleep problems without being sedative is a key advantage for depressed patients who frequently suffer from sleep disturbances associated with their depression”, points out Christian Guilleminault, MD, from Stanford University Sleep Disorders medical institution , California.

Due to its unique pharmacological profile, Valdoxan is the only anti depression medicate to have a specific action on circadian rhythms, which are often imbalanced in depressed patients. By improving disturbed wake-sleep patterns, according to Dr Guilleminault, Valdoxan is able to relieve sleep complaints of depressed patients with a favourable impact on daytime vigilance.

Tolerability profile

Data presented by Professor Montgomery shows that Valdoxan provides anti depression medicate efficacy, but lacks typical anti depression medicate side effects. The new agent does not appear to impair sexual function. A meditate comparing Valdoxan with Effexor(Venlafaxine) showed comparable anti depression medicate efficacy of both a cures, but significantly less sexual dysfunction of Valdoxan compared to the SNRI. In addition, a placebo-controlled, double-blind meditate comparing Valdoxan with Paxil(Paroxetine) showed that, after one week of a cure discontinuation, no signs of discontinuation symptoms* were seen in the agomelatine group compared to significant discontinuation symptoms in the Paxil(Paroxetine) group.2

Valdoxan was discovered and developed by Servier. The drug is currently in Phase III and a registration dossier for an indication in MDD was recently submitted to the European Regulatory Agency (EMEA).

Discontinuation symptoms occur when a cure with certain anti depression medicates (mainly SSRIs and SNRIs) is stopped. They can include nausea, headache, dizziness, sleep disturbances, anxiety and irritability.

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For further information, please contact:
Moira Gitsham, Tonic Life Communications (+33 5 46 00 08 20, moira.gitsham@toniclc.com)
or
Matthew Kent, Tonic Life Communications (+44 207 798 9900, matthew.kent@toniclc.com)
References
1 L�o H, Hale A, D’haenen H. Int Clin Psychopharmacol. 2002; 17:239-247
2 Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I. Int Clin Psychopharmacol. 2004; 19 :271-280

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