Posted by bodhisattva_guy on February 5, 2011, at 2:14:12
In reply to UPDATE: The whole Story (Valdoxan experience), posted by hansi555 on January 29, 2011, at 8:35:56
I have never heard of this medication, looking it up it seems that in a year it might be available in US. So I assume I am not alone, and would like to detail this med:
Agomelatine (trade names Valdoxan, Melitor, Thymanax) is an antidepressant developed by the pharmaceutical company Servier. It is marketed for the treatment of major depressive disorder and has been reported to have a reduced level of sexual side effects as well as discontinuation effects compared to some other antidepressants. Agomelatine may also have positive effects on sleep....It increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin. Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.[2]
http://en.wikipedia.org/wiki/Agomelatine
Suggestion: please use generic name - as it is likely that this medication will be called somewhat differently when introduced in the US.
Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Binding studies indicate that it has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.[2]"Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd. Servier continued to develop the drug and conduct phase III trials in the European Union. In March 2005 Servier submitted agomelatine to the European Medicines Agency (EMEA) under the trade names Valdoxan and Thymanax.[3] On 27 July 2006 the Committee for Medical Products for Human Use (CHMP) of the EMEA recommended a refusal of the marketing authorisation of Valdoxan/Thymanax (agomelatine). The major concern was that efficacy had not been sufficiently shown. The CHMP had no special concerns about side effects.[3] In September 2007, Servier submitted a new marketing application for Valdoxan (agomelatine) to the EMEA.[4] On 20 November 2008, Valdoxan was given a positive opinion, with restrictions,[5] by the EMEA,[4] and was subsequently given marketing authorisation in the European Union on 20 February 2009.[6] Release dates in the individual countries of the EU were dependent on marketing arrangements.
In March 2006, Servier announced it had sold the rights to market agomelatine in the United States to Novartis.[7] It is currently undergoing phase III clinical trials in the US. Novartis lists the drug as scheduled for submission to the FDA no earlier than 2012.[8] It is currently sold in Australia under the Valdoxan trade name."
poster:bodhisattva_guy
thread:978061
URL: http://www.dr-bob.org/babble/20110130/msgs/978685.html