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New Melatonergic Antidepressant Combines Efficacy With Very Favourable Side-Effect Profile
Amsterdam, The Netherlands (ots/PRNewswire) -
- Valdoxan(R) (agomelatine) Provides Antidepressant Efficacy With the Additional Clinical Benefit of Sleep Improvement With no Effect on Daytime Vigilance
The first melatonergic antidepressant, Valdoxan(R) (agomelatine), offers an innovative new approach to the treatment of depression. Valdoxan combines antidepressant efficacy, even in severely depressed patients, with an extremely favourable side-effect profile and has the additional benefit of sleep regulation in depressive patients, according to new data presented at the 18th Congress of the European College of Neuropsychopharmacology (ECNP) today. The ability of Valdoxan to relieve depressive patients' sleep disruption without affecting daytime vigilance is a key advantage for an antidepressant medicine as sleep complaints are a very common and disabling feature of depression.
Antidepressant efficacy and additional clinical benefits
Valdoxan was shown to be an effective antidepressant, by reducing the initial HAMD score to a similar extent to that of the selective serotonin reuptake inhibitor (SSRI) paroxetine and significantly greater than placebo (1). Results from two other clinical trials presented in Amsterdam show that Valdoxan also has a similar efficacy to the serotonin noradrenergic reuptake inhibitor (SNRI) venlafaxine, but not the often observed side-effects associated with the SNRI. Preliminary results of a specific study comparing Valdoxan (25 - 50 mg / day) with venlafaxine (75 - 150 mg / day) in depressed patients showed that Valdoxan had a similar antidepressant effect. However, Valdoxan treatment resulted in significantly better and earlier improvement in initiating sleep (p<0.001). In addition, a polysomnography study in depressed patients showed that Valdoxan 25 mg had a beneficial effect on sleep architecture.
"In addition to its effective antidepressant properties, Valdoxan is the only antidepressant to have a specific action on circadian rhythms", says Dr Raymond Lam from the Department of Psychiatry, University of British Columbia, Canada. "It can relieve sleep complaints in depressed patients without residual impairment and thus appears to be an innovative, new pharmacological treatment for depression."
Further studies versus placebo and comparators have confirmed the antidepressant efficacy of Valdoxan in adults of all ages, including elderly depressed patients.(1, 2) In addition, Valdoxan has shown particularly interesting results in severely depressed patients; its antidepressant efficacy increased as the severity of the depression increased, including in patients with a HAMD>30, therefore providing clear patient benefits.
Excellent side-effect profile
Valdoxan has an innovative pharmacological profile; it is the first melatonergic antidepressant acting as a MT1 and MT2 receptor agonist with additional 5-HT2C receptor antagonist properties. Due to this unique mode of action, it does not show the typical side effects found with SSRIs and SNRIs, in particular sexual dysfunction and drug discontinuation symptoms(i), two common side-effects that patients find particularly troubling.
A trial comparing Valdoxan with venlafaxine showed comparable antidepressant efficacy of both treatments, but significantly less sexual dysfunction with Valdoxan. In addition, a placebo-controlled, double-blind study comparing Valdoxan with paroxetine showed that, after one week of treatment discontinuation, no signs of discontinuation symptoms were seen in the Valdoxan group compared to significant discontinuation symptoms in the paroxetine group.(3)
A new and effective approach to depression treatment
Patient acceptability of antidepressants is a major concern and is still one of the unmet needs in treating depression. Special emphasis has been given to the acceptability of Valdoxan throughout its clinical development programme, in particular its effect on sexual dysfunction and drug discontinuation symptoms.
Valdoxan was discovered and developed by Servier. The drug is currently in Phase III trials and a registration dossier for an indication in major depressive disorder (MDD) was submitted to the European Regulatory Agency (EMEA) in 2005.
(i) Discontinuation symptoms occur when treatment with certain antidepressants (mainly SSRIs and SNRIs) is stopped. They can include nausea, headache, dizziness, sleep disturbances, anxiety and irritability.
1. Lôo H, Hale A, D'haenen H. Int Clin Psychopharmacol. 2002; 17:239-247
2. Emsley, CINP 2004; Int.J.Neuropsychopharm. 2004; Vol 7; suppl 1: P02.174
3. Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I. Int Clin Psychopharmacol. 2004; 19 :271-280
ots Originaltext: Servier
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