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Dr. Bob is Robert Hsiung, MD,
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Posted by Marty on September 2, 2008, at 18:31:29
September 2: Agomelatine better than Zoloft (Sertraline)http://www.docguide.com/news/content.nsf/news/852571020057CCF6852574B8006445A8
I hope EMEA respect Dr.Kasper ..
/\/\arty
Posted by Marty on September 2, 2008, at 18:39:22
In reply to Agomelatine: Good news, posted by Marty on September 2, 2008, at 18:31:29
I was wondering if Dr.Kasper was respected enough to influence the EMEA to approve Agomelatine: Well guess what ?"Dr.Kasper ...is also an adviser to the European Agency for the Evaluation of Medicinal Products (EMEA)."
This isn't good news.. this is VERY good news.
Source: http://www.litebook.com/support/skasper.asp
/\/\arty
Posted by ricker on September 2, 2008, at 19:06:54
In reply to Setp 2: Agomelatine SUPERIOR to Zoloft » Marty, posted by Marty on September 2, 2008, at 18:39:22
That is very good news! I hate wating for the new and improved versions.
How come Europe seems ahead as far as new drug development?
I would think North America capable of developing newer meds. Well, maybe not here in Canada, but geez, I was never one for patiently waiting to open any of my presents and I was emotionaly stable back then!!!Rick
Posted by Phillipa on September 2, 2008, at 19:22:48
In reply to Re: Setp 2: Agomelatine SUPERIOR to Zoloft, posted by ricker on September 2, 2008, at 19:06:54
Luvox was in Europe first also and approved there for both depression and OCD sometimes they are ahead of us wonder if it's the FDA? Phillipa
Posted by desolationrower on September 2, 2008, at 23:00:35
In reply to Re: Setp 2: Agomelatine SUPERIOR to Zoloft » ricker, posted by Phillipa on September 2, 2008, at 19:22:48
Servier is like a pharmaceutical company from outer space.
-D/R
Posted by desolationrower on September 2, 2008, at 23:39:33
In reply to Re: Setp 2: Agomelatine SUPERIOR to Zoloft » Phillipa, posted by desolationrower on September 2, 2008, at 23:00:35
From the same announcement
Comparative efficacy of the antidepressants agomelatine, venlafaxine and sertraline print the Paper
Citation: European Neuropsychopharmacology The Journal of the European College of Neuropsychopharmacology, Volume 18 Supplement 4, Page S331
S. Kasper1, P. Lemoine2
1Medical University of Vienna, Department of General Psychiatry, Vienna, Austria
2Clinique Lyon Lumiere, Biological psychiatry, Lyon Bron, FranceBackground: Agomelatine is an novel antidepressant agent with a receptoral profile different from antidepressants currently in clinical use. Agomelatine is a potent agonist at melatonergic MT1 and MT2 receptors and an antagonist at 5HT2c receptors [1]. Clinical studies have demonstrated its efficacy for the treatment of major depressive disorder [2]. As statistical significance and clinical effectiveness are not synonymous, antidepressants need to demonstrate their ability to alleviate patients' symptoms in clinical practice. Furthermore, even in the case of good short-term efficiency, a valuable antidepressant needs to demonstrate its properties over long-term treatment. Moreover, to be useful in clinical practice, a new antidepressant needs to provide advantages in comparison with other drugs already commonly prescribed.
Purpose: To evaluate the clinical efficacy of agomelatine in comparison with venlafaxine and sertraline in clinical practice, for short-term and long-term symptom alleviation.
Methods: Two studies were selected: one comparing agomelatine (2550 mg/d,) with venlafaxine (75150 mg/d) [3], and a second comparing agomelatine (2550 mg/d,) with sertraline (50100 mg/d). In the first study, 165 patients were randomized to receive agomelatine and 167 to receive venlafaxine. In the second study, 154 patients were randomized to receive agomelatine and 159 to receive sertraline. Both studies were multicenter and conducted in double-blind. Treatment was for 6 weeks with an optional extension period of 6 months.
The results considered were those obtained from the Clinical Global Impression (CGI) rating scale, a scale developed to assess treatment response in mental disorders. It contains items such as severity of the Illness (CGI-S) and global improvement (CGI-I). The CGI scale is easy to use for clinicians and directly reflects their clinical impression.
Results: Compared with venlafaxine, the clinical superiority of agomelatine appeared as early as week one (two tailed superiority test; P < 0.0001) the mean difference in between the two treatments being 0.39. This superiority of agomelatine was still significant, with a mean CGI-I difference of 0.32 (two tailed superiority test; P = 0.016, last observation carried forward) in comparison with venlafaxine after completion of the mandatory treatment period of 6 weeks. The extension to six months of this study showed that the mean score was statistically significantly lower in the agomelatine group than in the venlafaxine group (0.32; P = 0.025), with two-sided Student's test confirmed by the Mann Whitney test, thus indicating a better symptomatic improvement.
Compared to sertraline, treatment with agomelatine demonstrated a significant superiority (two-sided Student's test for independent samples) on CGI ratings both in the CGI severity of illness score (delta of 0.28; P = 0.043) and in the mean CGI global improvement score (delta of 0.29; P = 0.023) after 6 weeks of treatment (last observation carried forward).
Conclusions: The results show that agomelatine significantly improves CGI ratings in comparison with sertraline and venlafaxine, two commonly prescribed antidepressants. These results suggest that agomelatine could be clinically superior to sertraline and venlafaxine in clinical practiceReferences:
1. Audinot, V., Mailliet, F., Lahaye-Brasseur, C., et al. 2003 New selective ligands of human cloned melatonin MT1 and MT2 receptors. Naunyn-Schmiedeberg's Arch Pharmacol. 367:553561.
2. Kennedy, S.H. 2007 Agomelatine: an antidepressant with a novel mechanism of action. Future Neurol. 2:145151.
3. Lemoine, P., Guilleminault, C., Alvarez, E. 2007 Improvement of subjective sleep in major depressive disorder with a novel antidepressant, agomelatine: randomized, double-blind comparison with venlafaxine. J Clin Psychiatry.68:17231732.
Keywords:
Agomelatine
Antidepressants: clinical
Depression: clinical
http://ex2.excerptamedica.com/08ecnp/index.cfm?fuseaction=CIS2002&hoofdnav=Abstracts&content=abs.details&what=AUTHOR&searchtext=L&topicselected=*&selection=ABSTRACT&qryStartRowDetail=114only drawback is that 150mg might not be enough to capture full benefit of venlafaxine.
-D/R
Posted by Negcreep on September 3, 2008, at 9:29:28
In reply to hm: and aglomelatine is ) venlafaxine too, posted by desolationrower on September 2, 2008, at 23:39:33
Brilliant news, still hanging on for news from the EMEA on this one. They usually put out a monthly report on their website in the first week of each month....I'm hoping agomelatine is approved :)
Posted by Marty on September 3, 2008, at 14:24:25
In reply to Re: hm: and aglomelatine is ) venlafaxine too, posted by Negcreep on September 3, 2008, at 9:29:28
> Brilliant news, still hanging on for news from the EMEA on this one. They usually put out a monthly report on their website in the first week of each month....I'm hoping agomelatine is approved :)
---
I knew you'd like that news Neg :)Since Dr.Kasper(sp?) is an adviser of EMEA and on the approval commitee and since the EMEA concern wasn't about the safety but about the efficacy, I think it's now safe to expect Valdoxan to be approve in the next couple months.
That said I doubt it will be marketed this month or even the next. But I, for one, can wait as now I feel much better waiting for it knowing it WILL BE marketed. Nothing stands in the way of an European release now.BTW, I find it quite funny that the study has been financed by Servier and that the main investigator, Dr.Kasper, is on the EMEA approval board ! .. Could you imagine that in the US ? Glaxo Smith Kline, in the 90's, financing a trial for Paxil in which the responsible of the trial is on the approval board of the FDA !? .. that would be one HUGE scandal. Well, it seems to be good practice in Europe and that's just flabbergasting.
/\/\arty
Posted by ihatedrugs on September 4, 2008, at 0:27:03
In reply to Re: hm: and aglomelatine is ) venlafaxine too » Negcreep, posted by Marty on September 3, 2008, at 14:24:25
When is this med going to be released in the US.
I'm actually excited about its low side effects profile. Ah, I have a reason to hope if only for a few months.
Is this med similar in any way to Cymbalta? Because if it is I will not touch it. I'm still trying to get over the withdrawal effects since June. Eli Lily should be sued for allowing so much suffering by not disclosing the difficulty in stopping this med.Greetings,
ihatedrugs
Posted by Negcreep on September 4, 2008, at 9:47:26
In reply to Re: hm: and aglomelatine is ) venlafaxine too » Negcreep, posted by Marty on September 3, 2008, at 14:24:25
Hey I checked out this Dr Kasper, and hes just an adviser to the EMEA approval board not an actual member of it :)
But it certainly sounds like hes putting the case forward for approval, with the recent news.The list of members from the The Committee for Medicinal Products for Human Use (CHMP)of the EMEA can be found here:
http://www.emea.europa.eu/htms/general/contacts/CHMP/CHMP_members.htmlNeg
Posted by Abby Cunningham on September 4, 2008, at 11:04:49
In reply to Agomelatine: Good news, posted by Marty on September 2, 2008, at 18:31:29
There is a clinical trial going on at UMass Medical Center in Worcester, MA. My pdoc said I could be in on it if I gave up therapy while in the trial - that's the condition put by the drug company i guess. I am not willing to do that just yet but I cannot wait for Valdoxan to be approved. It sounds too good to be true
Posted by Netch on September 6, 2008, at 5:45:26
In reply to Re: hm: and aglomelatine is ) venlafaxine too, posted by ihatedrugs on September 4, 2008, at 0:27:03
> When is this med going to be released in the US.
> I'm actually excited about its low side effects profile. Ah, I have a reason to hope if only for a few months.
> Is this med similar in any way to Cymbalta? Because if it is I will not touch it. I'm still trying to get over the withdrawal effects since June. Eli Lily should be sued for allowing so much suffering by not disclosing the difficulty in stopping this med.
>
> Greetings,
> ihatedrugsIf it's approved by the FDA it will be released in the US within 12-24 months
Posted by NegCreep on September 8, 2008, at 17:53:16
In reply to Re: hm: and aglomelatine is ) venlafaxine too, posted by ihatedrugs on September 4, 2008, at 0:27:03
This drug is nothing like cymbalta or anything like any of the SSRIs SNRIs etc currently on the market. Its apparently a very effective antidepressant and has a side effect profile similar to placebo and no assiociated withdrawl syndrome on stopping it.
Do you see why we all want it so much now :)
Posted by Marty on September 25, 2008, at 11:09:32
In reply to Re: Setp 2: Agomelatine SUPERIOR to Zoloft, posted by ricker on September 2, 2008, at 19:06:54
I've created a new thread with all the info !
http://www.dr-bob.org/babble/20080915/msgs/853983.html
/\/\arty
This is the end of the thread.
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