Novartis and Servier reach agreement on novel Major Depression drug
posted Thursday, 30 March 2006
Novartis And Servier Reach Agreement On Novel Major Depression Drug
Basel, Switzerland, March 29, 2006 - Novartis and Servier announced today the signing of a licensing agreement for agomelatine, a Phase III investigational drug for the treatment of major depressive disorder, a condition estimated to affect one in ten adults in the US alone.
Under development as a once-daily treatment, agomelatine is a novel melatonergic antidepressant that acts as an agonist at MT1 and MT2 receptors with additional 5-HT2c antagonist properties. Due to its unique receptor profile, agomelatine represents a potential innovation for the pharmacological treatment of depression.
The efficacy, tolerability and safety of agomelatine has been assessed in several double-blind, randomized, placebo- and active-controlled Phase III studies conducted by Servier, mainly in Europe, Canada and Australia. In the active-controlled studies, which utilized a commonly prescribed product for the treatment of major depression, the effect of agomelatine was similar to that of the active-control.
In general, the number of adverse events experienced in patients treated with agomelatine during these studies was comparable to placebo. The main adverse events were dizziness, headache and nausea1. Additionally, the tolerability and safety profile of agomelatine includes a lack of clinically significant weight gain, no apparent effects on sexual function (particularly as compared with the active-control), a low incidence of gastro-intestinal adverse events as well as absence of discontinuation symptoms upon withdrawal 1,2,3,4.
References:- Rouillon F,
Efficacy and tolerance profile of agomelatine and practical use in depressed patients.
Int Clin Psychopharmacol. 2006;21 Suppl 1:31-5 [Abstract]
- Loo H, Hale A, D'haenen H.
Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study.
Int Clin Psychopharmacol. 2002;17(5):239-47. [Abstract]
- 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(5):271-80. [Abstract]
- Kennedy SH, Emsley R.
Placebo-controlled trial of agomelatine in the treatment of major depressive disorder.
Eur Neuropsychopharmacol. 2006 16:93-100. [Abstract]
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