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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 15 of 15. This is the beginning of the thread.
Posted by Marty on September 23, 2008, at 18:46:06
In another thread, Rotem asks about Agomelatine:
> can we do something to hurry it's marketing?
> I can't wait.
---Here's my point of view... do you agree with me ?
->
Funny you ask. I asked myself the same question. A petition (with signatures in the thousands.. ~2000?) and a clever open letter endorsed by one or two Psychiatrists (preferably 1 from Europe(France) and 1 from USA) that we would try to get published in the best medical journal we could .. that could be helpful to Servier/Novartis.I think it's feasable. The main point of the open letter to the EMEA/FDA could be the need for more atypical antidepressants for treatment resistant people. The EMEA/FDA wants to approve meds that are proven superior to the one already on the market and that's a bad thing for treatment resistant / treatment intolerant people. I don't care if an -ATYPICAL- AD works only for 20% of the people since those AREN'T marketed as first line treatment. What's count is to have as much as different ADs with different mechanism of action that we can! .... that said, Agomelatine has been proven superior to Paroxetine and Sertraline in a couple of trials but doubts will remain as long as Servier doesn't finance more trials. My opinion ? Agomelatine is pretty safe and the EMEA/FDA shouldn't care much about more trials to confirm superiority of it: Even if it works on 2 time LESS people than Paroxetine or Sertraline IT DOESN'T MATTER SINCE IT'S A NEW CLASS OF ATYPICAL ANTIDEPRESSANT. People are waiting in suffering for those atypicals.. could they wait for the next in the SAME CLASS before bitching about superiority ?
/\/\arty
Posted by mike1975 on September 23, 2008, at 20:19:06
In reply to Agomelatine Approval .. Who's with me ?, posted by Marty on September 23, 2008, at 18:46:06
I completly agree with you. If it is up to me I would allow medication to be available after Phase II trails. If the meds in Phase I/II are proven to be reasonably safe let's try these meds in real world. My view is it should be up to patient and doctor to weight pro/cons and make decisions. We make decisions all the time, often complicated and serious ones. Why can't we evaluate the new medicine? I believe the real world whould judge the new meds faster and more accurate than all Phase III trails.
Mike
Posted by Nadezda on September 24, 2008, at 9:53:22
In reply to Agomelatine Approval .. Who's with me ?, posted by Marty on September 23, 2008, at 18:46:06
I'm all for anything that would make a difference in the production of more and better ADs. I'm not sure that a petition would do any good-- the drug companies make decision based on profits-- and costs of developing things-- They seem to want only blockbuster drugs, which is of course a terrible shame for those of us who respond to other, less commonly used drugs.
I'd sign a petition, but I don't know that it would make any difference.
Nadezda
Posted by Marty on September 24, 2008, at 16:01:06
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by Nadezda on September 24, 2008, at 9:53:22
> the drug companies make decision based on profits-- and costs of developing things--
---
Hi Nadezda,The letter/petition would be for the people who approves the drugs (FDA/EMEA), not the pharmaceutical companies. In this case it would be to both FDA and EMEA regarding Agomelatine. We would encourage them to approve Valdoxan (Agomelatine) on the basis that as a new class of atypical antidepressant (new mechanism of action) it could help many treatment resistant sufferers. The point is that because it's an atypical of a new class it doesn't need to be superior to already marketted ADs. Think about it: What's best ?
A) a new AD of an already existing class which would be effective for more people than the others of the same class. (ex. New-AD 56% vs Old-ADs 49%)
B) a new AD of a new class who would works for less people than other ADs already on the market (ex. New-AD 44% vs Old-AD 49%) BUT would works for lets say 15% of the treatment resistant people. (because it works in a new way..)
I vote for B. The problems is that what the FDA/EMEA are looking to approve is ADs SUPERIOR in terms of how much people helps and to which extent, NOT ADs which are inferior on those terms but DIFFERENT and so works for people for who the 'more-of-the-same-thing' ADs doesn't helps much.In 20 years from now, I think it would be best to have enough different ADs to be able to help 100% of the people THAN to have fewer but superior (in terms of responders %) so that the Treatment-Responder people would have to try less ADs before finding the good one for them BUT having in 2028 about the same amount of treatment- resistant people.
Those Atypical ADs should be fasttracked as soon as they are proven SAFE and AS GOOD as any decent antidepressants on the market.
Is that your feeling too ?
/\/\arty
Posted by Nadezda on September 24, 2008, at 16:59:02
In reply to Re: Agomelatine Approval .. Who's with me ? » Nadezda, posted by Marty on September 24, 2008, at 16:01:06
I agree new ADs should be fast-tracked if they're safe and at least somewhat effective. I guess I'd like to see some showing of effectiveness, because there are often unanticipated SEs and also just going through many drugs trials is a cost for people. But definitely if they're as effective-- I don't see the reason to insist they be more effective, for all the reasons you state. There are way too many people for whom no AD works, or even if it reduces symptoms, doesn't really work as much as one would want-- not to mention drugs that work for a while and lose efficacy.
So, yes, I agree new types of ADs are especially important.
My pdoc told me one time that it's far more difficult to get an AD approved than a drug for cancer or heart disease-- and the SEs have to be almost negligible, because depression and other mood disorders aren't taken seriously. On one level, I see their point-- but they underestimate the devastating impace of suffering from depression.
Also, a lot of drugs for depression are found only because they're used for something else-- and it's seen that a SE is that people with the disorder do better emotionally.
Do you think a petition would really make any difference with the FDA or EMEA?
Nadezda
Posted by Marty on September 24, 2008, at 17:16:04
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by Nadezda on September 24, 2008, at 16:59:02
Hi Nadezda,
I agree with everything you said.
> Do you think a petition would really make any difference with the FDA or EMEA?
---
Depending on the amount of signature and the credibility of the 1 or 2 Psychiatrist supporting the open letter, yes. Very unlikely that it would make them approve a drug that they wouldn't have approved anyway, but the whole idea is to speed up things.. to let them know that people are watching them, scrutinizing them and expecting from them. If published in a medical journal, it would also stimulate (slightly) discussions between some people in the field and increase interest in this drug. Historically, Americans aren't very fond of Servier psychopharmalogical drugs and telling them (the FDA) we care about those would make them less comfortable in blocking the approval of those drugs in America: Amineptine BLOCKED. (Not only blocked here, but the FDA also pressurized Servier to withdraw it from other countries!), Tianeptine (Hard entry, so somehow passively blocked)... and now they are ****ing about Agomelatine ? There's no reason./\/\arty
Posted by rotem on September 24, 2008, at 18:20:40
In reply to Re: Agomelatine Approval .. Who's with me ? » Nadezda, posted by Marty on September 24, 2008, at 17:16:04
to Marty:
I'm with you, and thinking exactly like you.
And I'm willing to do anything that is needed to speed agomelatine's marketing.
(I apologize for not elaborate more, that's is because I'm not an english speaker)
Posted by subconscious101 on September 25, 2008, at 0:53:17
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by mike1975 on September 23, 2008, at 20:19:06
I am totaly with you on this i was on it for six months and its easly the safest antidepressent i have ever taken. On another note i have just been recently informed that Valdoxan has just gained approval in ukraine. I also believe that there is alot of information about this medication that is beeing suppressed through the drug companies.
Posted by subconscious101 on September 25, 2008, at 3:29:37
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by subconscious101 on September 25, 2008, at 0:53:17
Some new info. http://www.presseportal.de/pm/57381/1065764/servier?search=novartis
I figure i will start contributing around here more to help give hope to the people who are in crisis with depression.
Posted by clipper40 on September 25, 2008, at 4:19:06
In reply to The greater the severity of depression, the greate, posted by subconscious101 on September 25, 2008, at 3:29:37
Thanks, you've already given some of us hope by renewing the conversation about agomelatine!
I'm hoping that since it has been approved in the Ukraine, that it's only a (short) matter of time for it to become available for the rest of us to order.
Posted by Marty on September 25, 2008, at 8:47:59
In reply to The greater the severity of depression, the greate, posted by subconscious101 on September 25, 2008, at 3:28:53
> Some new info. http://www.presseportal.de/pm/57381/1065764/servier?search=novartis
---
You too have subscribe to Google Alert with the term Agomelatine right ? Sometime, for no appearant reason Google Alert sends you an old page. Like this one... look at the date in the page... in 2007 :P
> I figure i will start contributing around here more to help give hope to the people who are in crisis with depression.
---
Great :)
Posted by Marty on September 25, 2008, at 8:51:48
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by subconscious101 on September 25, 2008, at 0:53:17
> I am totaly with you on this i was on it for six months and its easly the safest antidepressent i have ever taken.
---
Always glad to hear that from you :) ... btw, did you found AGO to be good for anxiety ?On another note i have just been recently informed that Valdoxan has just gained approval in ukraine.
---
That's pretty exciting.. where did you read about that ? plz share some links with us !> I also believe that there is alot of information about this medication that is beeing suppressed through the drug companies.
---
Sounds like a bad thing to me. What could it be and what makes you believe that ?
/\/\arty
Posted by Marty on September 25, 2008, at 9:08:04
In reply to Re: The greater the severity of depression, the gr » subconscious101, posted by clipper40 on September 25, 2008, at 4:19:06
According to an economic paper IN FRENCH, Valdoxan (Agomelatine) is approved not only in Ukraine but also in RUSSIA ! .. Trust me, my french is perfect and that's what it says. Let me traduce it to you..."Ces sommes ont permis la mise en production de trois nouvelles molécules : livabraside, le ranélate de strontium (Protelos) contre lostéoporose et lagomélatine (Valdoxan) utilisé dans le traitement des dépressions et qui est commercialisée en Russie et en Ukraine et qui est en attente dune autorisation de mise sur le marché en France."
Traduction: "Those investments allowed the beginning of the production of 3 new molecules : Ivabraside, Strontium Renelate (sp?) (Protelos) both fo osteoporosis and Agomelatine (Valdoxan) which is used to treat depressions and WHICH IS MARKETED IN RUSSIA AND IN UKRAINE and which is waiting to be approve in France."
The article is dated from 7/07/2008 14:09
Link: http://www.drakkaronline.com/Le-laboratoire-pharmaceutique
I'll start a new thread about it as I think it's time we search together what's cooking in Russia.. if you know what I mean ;)/\/\arty
Posted by Marty on September 25, 2008, at 9:23:52
In reply to Yes, It's even approved in RUSSIA !, posted by Marty on September 25, 2008, at 9:08:04
So far I can't find any other source who claims AGO is approved there. Anyone could ?/\/\arty
Posted by Marty on September 25, 2008, at 10:47:19
In reply to Re: Yes, It's even approved in RUSSIA ! » Marty, posted by Marty on September 25, 2008, at 9:23:52
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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