Posted by SLS on April 4, 2005, at 22:41:25
MUNICH, Germany, April 5 /PRNewswire/ --- First Melatonergic Agonist Antidepressant Shows Efficacy and Tolerability
Benefits Over Existing TherapiesValdoxan(R) (agomelatine), the first melatonergic (MT1 and MT2 receptor)
agonist antidepressant, is an innovation in the treatment of depression
with several advantages over existing treatments according to data
presented during the 13th Congress of the Association of European
Psychiatrists. Besides being an effective antidepressant, 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 antidepressant
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 antidepressant efficacy of Valdoxan has been shown at a standard dose
of 25 mg, once daily in the evening, in a dose-ranging study performed in
major depressive disorder (MDD)(1). In this multicentre,
placebo-controlled, dose-ranging study over eight weeks, Valdoxan was shown
to be an effective antidepressant at a dose of 25 mg once daily, by
reducing the initial HAMD score to a similar extent to that of the SSRI
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 another clinical trial
presented here in Munich show that Valdoxan has a similar efficacy to the
SNRI 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 Clinic, California.Due to its unique pharmacological profile, Valdoxan is the only
antidepressant 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
antidepressant efficacy, but lacks typical antidepressant side effects. The
new agent does not appear to impair sexual function. A study comparing
Valdoxan with venlafaxine showed comparable antidepressant efficacy of both
treatments, but significantly less sexual dysfunction of Valdoxan compared
to the SNRI. 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(i) were seen in the
agomelatine group compared to significant discontinuation symptoms in the
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).(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.References
1. Lôo 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
poster:SLS
thread:479920
URL: http://www.dr-bob.org/babble/20050404/msgs/479920.html