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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 25. This is the beginning of the thread.
Posted by Marty on November 21, 2008, at 9:09:35
Article from yesterday, Nov 20 2008:
http://www.pharmalive.com/News/index.cfm?articleid=587402&categoryid=51
/\/\arty
Posted by B2chica on November 21, 2008, at 10:20:27
In reply to Agomelatine -) 67 days before EMEA decision., posted by Marty on November 21, 2008, at 9:09:35
i can't see the article? would like to.
Posted by Marty on November 21, 2008, at 10:28:00
In reply to Re: Agomelatine -) 67 days before EMEA decision. » Marty, posted by B2chica on November 21, 2008, at 10:20:27
> i can't see the article? would like to.
You don't see the link to it in my post ? Cause I can't copy/past the article here.
Goggle for the name of the article which is "Committee for Medicinal Products For Human Use Summary of Positive Opinion for Valdoxan" then it's the first at the top of the search results.
/\/\arty
Posted by B2chica on November 21, 2008, at 10:52:42
In reply to Re: Agomelatine -) 67 days before EMEA decision. » B2chica, posted by Marty on November 21, 2008, at 10:28:00
i see your link. when i click on it i go to the article page but all it shows me is the title. nothing else...maybe i'm having internet trouble?
do i need to belong to the site inorder to read the article?
b2c.
Posted by B2chica on November 21, 2008, at 10:54:48
In reply to Agomelatine -) 67 days before EMEA decision., posted by Marty on November 21, 2008, at 9:09:35
it was network issues. i restarted my system and now i see the article.
thanks
b2c.
Posted by Phillipa on November 21, 2008, at 11:00:22
In reply to Re: Agomelatine_got it » Marty, posted by B2chica on November 21, 2008, at 10:54:48
Marty link works for me thanks Phillipa
Posted by jrbecker76 on November 22, 2008, at 9:24:49
In reply to Re: Agomelatine_got it, posted by Phillipa on November 21, 2008, at 11:00:22
Consider Agomelatine approved. The EC completely relies on the EMEA's CHMP subcommittee for its opinion. In terms of market launch though, there will now have to be some regulatory and pricing determinations made in each EU country, so a good approximate time frame for Servier to be able to get to market is around 6 months (each country will vary in timing).
http://www.servier.com/Pro/ContentPro.aspx?id=1181&=redirect
It might be a little longer for us on this side of the water. Novartis has now delayed its plan to submit agomelatine (AG) 178) until the 1st half of 09.JB
Posted by Marty on November 22, 2008, at 12:29:20
In reply to Re: Agomelatine - approved in Europe, posted by jrbecker76 on November 22, 2008, at 9:24:49
I agree. But regarding North America not only it could take a couple years but it also could never happen. The pretext would be the "common abnormalities of liver function tests (transaminase elevation > 3xULN)" vs the results (about half trial didn't show superiority over placebo) vs the positioning of Agomelatine: a light and easy AD (think Wellbutrin). While I say 'pretext' I think it would be of serious consideration but officiously more consideration could be given to market protectionism. Can you name a neuro/psycho pharmacologic drug by Servier marketed in North America ? I can't name one by Servier that didn't deserve to be approved here.. not even (especially?) Amineptine (Survector).If they (FDA/Health Canada) are to refuse Agomelatine because of health risks, AT LEAST they should consider a way to give easy access to the treatment resistant sufferers. A kind of special program but fast tracked: Did your patient failed at least 2 antidepressants from the 3 major class ? Yes ? Ok, is his liver functions checked and good ? Yes ? No prob.. just fax the form and attach a copy of the liver test results. That's it.. that shouldn't be more complicated than that.
/\/\arty---
> Consider Agomelatine approved. The EC completely relies on the EMEA's CHMP subcommittee for its opinion. In terms of market launch though, there will now have to be some regulatory and pricing determinations made in each EU country, so a good approximate time frame for Servier to be able to get to market is around 6 months (each country will vary in timing).
>
> http://www.servier.com/Pro/ContentPro.aspx?id=1181&=redirect
>
>
> It might be a little longer for us on this side of the water. Novartis has now delayed its plan to submit agomelatine (AG) 178) until the 1st half of 09.
>
> JB
Posted by CaptainAmerica1967 on November 22, 2008, at 14:37:21
In reply to Agomelatine -) 67 days before EMEA decision., posted by Marty on November 21, 2008, at 9:09:35
Currently in Phase III in the USA. May not be released in the UK until late 2009.
Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD:
www.neurotransmitter.net/newdrugs.html
Posted by Marty on November 22, 2008, at 15:00:41
In reply to Agomelatine -) 67 days before EMEA decision., posted by CaptainAmerica1967 on November 22, 2008, at 14:37:21
Hi Captain,
Agomelatine is in phase 3 indeed since a long time. Marketing in the 3rd and 4rd quarter is a possibility, yes.
Btw, www.neurotransmitter.net/newdrugs.html isn't always up to date and sometime wrong. If you're really into following the pipelines status I suggest you don't rely too much on them. It used to be updated frequently but this isn't the case since a couple months. A good example of what I'm talking about is Agomelatine status on their page: Agomelatine is approved and marketed in Ukraine since 2007 on the name Melitor (writen in ukranian.. can't paste the ukrainian here because the site doesn't support those characters but it looks like 'Mentop' in Latin characters) yet there's no mention of it on the page.
/\/\arty
---
> Currently in Phase III in the USA. May not be released in the UK until late 2009.
>
> Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD:
>
> www.neurotransmitter.net/newdrugs.html
Posted by desolationrower on November 22, 2008, at 15:09:34
In reply to Re: Agomelatine -) 67 days before EMEA decision. » CaptainAmerica1967, posted by Marty on November 22, 2008, at 15:00:41
I wonder if it wouldn't be easier for them to get it approved as a sleep drug than as an antidepressant.
-d/r
Posted by Marty on November 22, 2008, at 17:49:00
In reply to Re: Agomelatine -) 67 days before EMEA decision., posted by desolationrower on November 22, 2008, at 15:09:34
D/r,
My guess is that it would make the cut for sleep when compared to other non-benzo/melatonine agonist. But you can bet some will use it for that.. just like most prescription of Trazodone (Desyrel) are for sleep disturbance. Sometime they feel it's a good thing to have some antidepressant properties for some people. They just don't tell them. lol
/\/\arty
> I wonder if it wouldn't be easier for them to get it approved as a sleep drug than as an antidepressant.
>
> -d/r
Posted by jrbecker76 on November 24, 2008, at 1:13:55
In reply to Re: Agomelatine -) 67 days before EMEA decision. » CaptainAmerica1967, posted by Marty on November 22, 2008, at 15:00:41
> Hi Captain,
>
> Agomelatine is in phase 3 indeed since a long time. Marketing in the 3rd and 4rd quarter is a possibility, yes.
>
> Btw, www.neurotransmitter.net/newdrugs.html isn't always up to date and sometime wrong. If you're really into following the pipelines status I suggest you don't rely too much on them. It used to be updated frequently but this isn't the case since a couple months. A good example of what I'm talking about is Agomelatine status on their page: Agomelatine is approved and marketed in Ukraine since 2007 on the name Melitor (writen in ukranian.. can't paste the ukrainian here because the site doesn't support those characters but it looks like 'Mentop' in Latin characters) yet there's no mention of it on the page.
>
> /\/\arty
>
> ---
> > Currently in Phase III in the USA. May not be released in the UK until late 2009.
> >
> > Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD:
> >
> > www.neurotransmitter.net/newdrugs.html
>
>Marty,
I actually created and update the R&D list on Neurotransmitter.net. Due to the busy schedules of both myself and Shawn Thomas (the developer/host of neurotransmitter.net), we don't get around to posting an update except every couple months or so. As for covering drug approvals outside the U.S./EU (e.g., Ukraine), I rarely include them as the audience is mostly intended for the aforementioned regions. The list is not completely comprehensive. I typically try to make sure I cover all drug compounds in phases II and III, but also include phase I and preclinical compounds of interest when at all possible. I do not include supplemental new drug applications (aka drugs that are already on the market for a different indication) unless they seem to garner significant attention.
Since the website is not always updated every month, I sometimes get around to posting more frequent updates to my account on Scribd.com....
JB
Posted by Marty on November 24, 2008, at 9:33:43
In reply to Re: Agomelatine -) 67 days before EMEA decision. » Marty, posted by jrbecker76 on November 24, 2008, at 1:13:55
> I actually created and update the R&D list on
> Neurotransmitter.net.
---
Nice coincidence :) Are you also the owner of the site or is it Shawn ?> As for covering drug approvals outside the
> U.S./EU (e.g., Ukraine), I rarely include them
> as the audience is mostly intended for the
> aforementioned regions.
---
I realize all the work it would take to make and update this page for more than just the FDA and EMEA.
> The list is not completely comprehensive.
---
Maybe not but it includes the major players in the pipelines and, except if you're an market analyst in the pharma industry, is way enough like that.
> Since the website is not always updated every month, I sometimes get around to posting more frequent updates to my account on Scribd.com....
> http://www.scribd.com/doc/4407550/Future-Treatments-for-DepressionAnxiety-Psychosis-Sleep-disorders-and-AttentionDeficit-Hyperactivity-Disorder-ADHD-updated112208
---
Nice to know.. bookmarked.Even if it's not always up to date (not that important anyway), it's quite a good reference.
So thank you for that page JB./\/\arty
Posted by Marty on November 24, 2008, at 9:39:45
In reply to Re: Agomelatine -) 67 days before EMEA decision. » Marty, posted by jrbecker76 on November 24, 2008, at 1:13:55
JB,
Btw, I just saw in your Scribd version "EU: Approved" for Agomelatine. You consider CHMP positive opinion about Agomelatine as good as a real approval from the EMEA ? Is it your interpretation that there's no way the EMEA wouldn't approve a drug that the CHMP would approve or is it just an error ? If it's not an error than I'd like to have your opinion.
/\/\arty
Posted by jrbecker76 on November 24, 2008, at 11:32:37
In reply to Re: Agomelatine -) 67 days before EMEA decision. » jrbecker76, posted by Marty on November 24, 2008, at 9:39:45
> JB,
>
> Btw, I just saw in your Scribd version "EU: Approved" for Agomelatine. You consider CHMP positive opinion about Agomelatine as good as a real approval from the EMEA ? Is it your interpretation that there's no way the EMEA wouldn't approve a drug that the CHMP would approve or is it just an error ? If it's not an error than I'd like to have your opinion.
>
> /\/\artyMarty,
Perhaps I should have been more correct in listing agomelatine in the EU as a "positive opinion" rather than "approved" however, yes, receiving a positive opininion from the CHMP subcommittee is approval from the EMEA, but now the European Commission has to finally approve it. However, unlike with FDA panel recommendations that are sometimes disagreed upon when the FDA subsequently makes an official approval decision on a particular drug, the EC has almost always followed suit from the EMEA. So no need to still cross your fingers on this one, just have to be somewhat patient. As mentioned in a prior post, Servier will have to work with the separate countries to determine pricing and further regulatory matters before actual launch. Each EU member state has its own procedures for the authorization that fall outside the scope of the centralized procedure.
As for Neurotransmitter.net, Shawn is the host of the site, I just contribute to it.
JB
Posted by Marty on November 24, 2008, at 22:22:29
In reply to Re: Agomelatine -) 67 days before EMEA decision. » Marty, posted by jrbecker76 on November 24, 2008, at 11:32:37
JrBecker,I'm not familiar with the ways of the EMEA and therefore I'm glad to learn that the way the EMEA works, CHMP positive opinion is a guarantee of EMEA approval.
As a Canadian, I don't think we'll see Agomelatine anytime soon. Here, Ziprasidone (FDA approval in 2001) just got marketed and no Aripiprazole (FDA approval in 2002) yet. That's the price we pay for not acting faster and stronger about our famous Canadian online pharmacies. This is in no way a secret or a conspiracy theory as it has been publicly reported and discussed in the media a couple years ago.
Can I ask you if you work in a field related to neurology / psychiatry ?
/\/\arty
> Perhaps I should have been more correct in listing agomelatine in the EU as a "positive opinion" rather than "approved" however, yes, receiving a positive opininion from the CHMP subcommittee is approval from the EMEA, but now the European Commission has to finally approve it. However, unlike with FDA panel recommendations that are sometimes disagreed upon when the FDA subsequently makes an official approval decision on a particular drug, the EC has almost always followed suit from the EMEA. So no need to still cross your fingers on this one, just have to be somewhat patient. As mentioned in a prior post, Servier will have to work with the separate countries to determine pricing and further regulatory matters before actual launch. Each EU member state has its own procedures for the authorization that fall outside the scope of the centralized procedure.
Posted by Cecilia on November 25, 2008, at 3:21:24
In reply to Re: Agomelatine -) 67 days before EMEA decision. » jrbecker76, posted by Marty on November 24, 2008, at 22:22:29
Seems like the article just discussed this drug's serotonin effects plus melatonin. How does it differ from a SSRI plus melatonin (which you can buy over the counter)? Cecilia
Posted by Marty on November 25, 2008, at 9:40:07
In reply to Re: Agomelatine how does it work?, posted by Cecilia on November 25, 2008, at 3:21:24
Hi Cecilia,Agomelatine 5-HT2c antagonism properties doesn't "increased serotonin level" but enhances the activity of frontocortical dopaminergic and adrenergic pathways. So SSRIs are mainly serotonergic and Agomelatine is dopaminergic/adrenergic/melatonergic. I say mainly because most of them have more properties than being serotonergic, exception being (Es)citalopram which is the most selective of the SSRIs. As example, Paroxetine (Paxil) as some DRI (Dopamine Reuptake Inhibition) properties and Prozac, which is famous for being the first blockbuster SSRI, is in fact an atypical SSRI because it has more significant 5-HT2c antagonism effect than a serotonin reuptake effect.
While you could very crudely emulate Agomelatine MT1/2 agonism with some Melatonin, I'm not aware of any supplement capable of 5-HT2c antagonism.
/\/\arty
---
> Seems like the article just discussed this drug's serotonin effects plus melatonin. How does it differ from a SSRI plus melatonin (which you can buy over the counter)? Cecilia
Posted by Henrik Jonsson on December 24, 2008, at 0:06:09
In reply to Re: Agomelatine how does it work?, posted by Marty on November 25, 2008, at 9:40:07
Doesn´t agomelatine increase serotonin-levels at all?
Posted by Henrik Jonsson on December 26, 2008, at 1:18:36
In reply to Re: Agomelatine how does it work?, posted by Henrik Jonsson on December 24, 2008, at 0:06:09
I think this is strange. If it is a 5htp antagonist, shouldn´t it increase serotonin levels?
Posted by psychobot5000 on December 27, 2008, at 18:51:05
In reply to Re: Agomelatine how does it work?, posted by Henrik Jonsson on December 26, 2008, at 1:18:36
> I think this is strange. If it is a 5htp antagonist, shouldn´t it increase serotonin levels?
As far as I understand, the answer is no. (it's actually a 5HT-antagonist, btw) If you look just at the title 5HT-antagonist, you might think it would actually block serotonin... But in the case of this drug, it only significantly blocks certain subfamilies of serotonin receptors, the 5HT-2b and 5HT-2c receptors. The latter is thought to be partly responsible for its antidepressant effects--blocking serotonin 2c receptors can apparently help relieve anxiety, better sleep, and increase dopamine levels in the frontal cortex, which could theoretically help with various other issues, i.e. concentration. Agomelatine also agonizes two families of melatonin (MT) receptors, which helps sleep and (researchers say) may also contribute to its antidepressant effects. However, I'm not aware that it has any effect on increasing (synaptic) serotonin levels in a general way.
Posted by Henrik Jonsson on January 15, 2009, at 6:01:36
In reply to Re: Agomelatine how does it work? » Henrik Jonsson, posted by psychobot5000 on December 27, 2008, at 18:51:05
so it will not help for ocd?
Posted by psychobot5000 on January 16, 2009, at 22:32:51
In reply to Re: Agomelatine how does it work?, posted by Henrik Jonsson on January 15, 2009, at 6:01:36
> so it will not help for ocd?
Hard to say, I think. Hitting serotonin receptors individually may very well help OCD, not just raising serotonin levels in general--clomipramine is likely more effective for OCD than SSRIs after all, and has both actions, though a weaker effect on serotonin levels than SSRIs. However, it's not clear whether blocking the 5ht-2c receptor specifically, as agomelatine does, will be helpful. Linkadge (who knows much more), I think it was, wrote some stuff about this a few weeks ago, and his perspective was skeptical. Theory would seem to suggest that it might not be the best option for OCD (but read on). But with some broadly similar medications (Remeron is the one I'm thinking of), some OCD sufferers have been helped, and some have found it counterproductive (according to Link). So it probably varies individually.
All that said, I have OCD and take Agomelatine, and frankly, it may be helping. It certainly helps in the evening, after I take a dose, and in the morning as well. Whether it helps in the afternoon (when blood levels of the drug are lowest) is unclear at this point--it might even be counterproductive, though only slightly. But I'm still early in the trial, and so far general signs are positive. Based on my experience, I'd suggest that yes, it's likely useful for OCD, at least for some patients.
Posted by Peter S. on January 19, 2009, at 11:37:09
In reply to Re: Agomelatine how does it work? » Henrik Jonsson, posted by psychobot5000 on January 16, 2009, at 22:32:51
Hi there,
Where are you getting the Agomelatine- the Ukraine? I didn't think it was available anywhere else.
Thanks
> > so it will not help for ocd?
>
> Hard to say, I think. Hitting serotonin receptors individually may very well help OCD, not just raising serotonin levels in general--clomipramine is likely more effective for OCD than SSRIs after all, and has both actions, though a weaker effect on serotonin levels than SSRIs. However, it's not clear whether blocking the 5ht-2c receptor specifically, as agomelatine does, will be helpful. Linkadge (who knows much more), I think it was, wrote some stuff about this a few weeks ago, and his perspective was skeptical. Theory would seem to suggest that it might not be the best option for OCD (but read on). But with some broadly similar medications (Remeron is the one I'm thinking of), some OCD sufferers have been helped, and some have found it counterproductive (according to Link). So it probably varies individually.
>
> All that said, I have OCD and take Agomelatine, and frankly, it may be helping. It certainly helps in the evening, after I take a dose, and in the morning as well. Whether it helps in the afternoon (when blood levels of the drug are lowest) is unclear at this point--it might even be counterproductive, though only slightly. But I'm still early in the trial, and so far general signs are positive. Based on my experience, I'd suggest that yes, it's likely useful for OCD, at least for some patients.
This is the end of the thread.
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