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Dr. Bob is Robert Hsiung, MD,
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Posted by juanantoniod on April 15, 2003, at 22:13:00
In reply to Re: Cymbalta/Duloxetine timing, posted by lansolut on April 14, 2003, at 19:03:55
All you have to do is call them. Unfortunately, all they will give you is definite information. No probablies, no maybes, nothing. Which, as I write this I realize is smart on their part, but I think we planners hope for some anticipated date.
> It would be great to be able to believe the August release date. Just curious, how does one get reliable information from Lilly?
Posted by val1224 on May 14, 2003, at 14:25:44
In reply to Re: Cymbalta/Duloxetine timing, posted by lansolut on April 14, 2003, at 19:03:55
CNS Neuroscience Institute was doing at least one of the duloxetine clinical trials for Lilly. Also, I participate in the Harris Poll surveys online and about 6-8 weeks ago received a survey from them which was all about Cymbalta. It was marketing-type questions. So, it looks like they are lining up their marketing for it.
Posted by Jack Smith on May 14, 2003, at 16:10:03
In reply to Re: Cymbalta/Duloxetine timing, posted by val1224 on May 14, 2003, at 14:25:44
> CNS Neuroscience Institute was doing at least one of the duloxetine clinical trials for Lilly. Also, I participate in the Harris Poll surveys online and about 6-8 weeks ago received a survey from them which was all about Cymbalta. It was marketing-type questions. So, it looks like they are lining up their marketing for it.
I didn't quite understand your post. What are the Harris Poll surveys? Also what does the clinical trials have to do with marketing it. Thanks in advance.
JACK
Posted by johnj on May 19, 2003, at 8:35:22
In reply to Re: Cymbalta/Duloxetine timing » val1224, posted by Jack Smith on May 14, 2003, at 16:10:03
end of the 4th quarter.
Hope the link works.
Appears it won't be until end of the year....Anybody seen a more recent update on the web or by phone?
Posted by Ben Bivens on June 15, 2003, at 18:34:56
In reply to Cymbalta/Duloxetine timing appears to be, posted by johnj on May 19, 2003, at 8:35:22
> end of the 4th quarter.
> Hope the link works.
> Appears it won't be until end of the year....Anybody seen a more recent update on the web or by phone?
>
> http://biz.yahoo.com/rc/030422/health_lilly_outlook_1.htmlGuys,
I have been interviewed by Innovex who apparently has made a 5 year deal with Lilly to help them represent Duloxetine. They said marketing and sales training would begin in mid and late june 2003, but he also said that we would not begin marketing right away, just training in Indianapolis. I'm leaning toward the end of summer release. Get ready to move some assets... Don't know if that helps but I'm looking forward to communicating on this posting site if all works out for me, and establishing a base of knowledge from you all.
Posted by sarah8 on July 2, 2003, at 9:04:26
In reply to Re: Cymbalta/Duloxetine timing » lansolut, posted by juanantoniod on April 15, 2003, at 22:13:00
I recently spoke with Lilly UK who informed that duloxetine will be out end of Q4 2003 .. so November/December time.
I followed up with BI and they said the same thing!!
Does anyone know if BI will call duloxetine something other than Cymbalta?
Posted by fendleywood on July 19, 2003, at 11:59:42
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on March 12, 2003, at 20:38:48
> I have just heard from a very reputable source that the tentative timeline for duloxetine's release is four months from now. Whether that means 'final approval' or 'time to market,' I'm not entirely sure. Although I can't reveal my source, I can tell you that he is on the Lilly advisory board for the drug.
>
> If any of you are day traders, I want a cut of your shares if you actually buy low and sell high that week.
>
> I lasted only two weeks in a reserach study using duloxetine for fibromyalgia. I never felt worse in my life...lethargy, confusion, aches/pains, depression like I never knew before. Obviously, I was not on the placebo.
Posted by JLM on July 21, 2003, at 1:49:52
In reply to Re: Cymbalta/Duloxetine timing, posted by fendleywood on July 19, 2003, at 11:59:42
What's with all the excitement over Cymbalta? After all, its just another dual uptake inhibitor, ala Effexor.
Here were are, after 60 years of progress in neuroscience, and we're still just manipulating SE and NE.
My prediction: Cymbalta will be no more effective than any other AD on the market.
Posted by SLS on July 21, 2003, at 7:01:33
In reply to Re: Cymbalta/Duloxetine timing, posted by JLM on July 21, 2003, at 1:49:52
> My prediction: Cymbalta will be no more effective than any other AD on the market.
Maybe, but it might be more effective for YOU or ME. That is what I care about. If you know of a single person who failed to respond to one SSRI and went on to respond to another, than you will have justified the second's existence. The more tools, the better. For every new drug that becomes available, a certain percentage of previously treatment-resistant people will respond to it. That is fact.I predict that Cymbalta will be a great addition to our arsenal - at least that is my hope.
- Scott
Posted by pseudonym on July 21, 2003, at 13:44:22
In reply to Re: Cymbalta/Duloxetine timing, posted by JLM on July 21, 2003, at 1:49:52
Manipulating SE and NE is such a broad and diverse area of research. Your dismissive statement of "just manipulating SE and NE" seems to conclude that any research into these two neurotransmitters is a failed avenue of research. Wrong.
For one, duloxetine has much lower K(i) values, which indicates it prevents re-uptake much more potently than Effexor, in vivo. Furthermore, it takes a lot less of it to do so, as indicated by much lower ED-50 values. Finally, it prevents re-uptake of NE at much lower dosage levels than Effexor. The clincal trial data is also promising, but I'm not going to reiterate that here. My prediction: You're going to come back with a mea culpa in 6-9 months, and be happy to do so.
Posted by John O'Connor on October 21, 2003, at 6:03:46
In reply to Re: Cymbalta/Duloxetine timing, posted by fendleywood on July 19, 2003, at 11:59:42
> > I lasted only two weeks in a reserach study using duloxetine for fibromyalgia. I never felt worse in my life...lethargy, confusion, aches/pains, depression like I never knew before. Obviously, I was not on the placebo.
>Hey Fendleywood,
I wasn't aware that duloxetine was going to be available for any other indications besides depression and stress-urinary incontinence. I certainly hadn't heard of any potential for its use in the treatment of fibromyalgia. Who ran this study? Any idea where I'd find details/results etc.?
Cheers,
John
Posted by pecos on November 12, 2003, at 0:18:38
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on July 21, 2003, at 13:44:22
In reading these posts, it sounds as if SE & NE are the end all be all of effective Anti depressents in this chat area.
What about Wellbutrin?? It is the only AD that address Dopamine reuptake and Norepinephrine reuptake.
There are more than 2 neurotransmitters in the brain!!
The monamone neurotransmitters include:
CATECHOLAMINES:
1) Norepinephrine
2) Epinephrine
3) DopamineAND
INDOLAMINES:
1) SerotoninRemember Effexor XR has serotonin which adds sexual dysfunction and weight gain. Wellbutrin has minimal sexual dysfunction and it is weight neutral. In fact some doctors are using it off label to lose weight...go figure.
Lexapro can make its claims but you still can't get it up and you will get poop out after about 4 to 6 months, which ties into the time you see weight gain of 10 pounds plus for most people.
Also if you are trying to address the max number of neurotransmitters. Dr Stahl (considered a thought leader of depression) has a cartoonish bubble presentation of the three primary neurotransmitters involved in depression showing Dopamine/ Norepinephrine/ Serotonin. This simplied presentation (because it is all really still theory)shows Serotonin is ideal for obsession and compulsion. Yes SE elevates Mood but long term use of SE suppresses Dopamine which leaves to food cravings and weight gain, SE causes loss of sexual libido (even a vibrator/ or long sessions of masturbation are futile...remember Sex & The City when Charlotte's sexaholic guy was put on Prozac. He did stop obsessing about sex and but he stated he couldn't have sex anymore! IT IS TRUE!) and the famous SSRI poop out. Plus Serotonin really affects sleep! People say SSRI's cause crazy dreams but the fact is SSRI's don't allow deep REM. Sleep studies show patients wake up many times when on SSRI's. The result of these awakenings is that patients remember all their dreams. Losely translated you have alot of wild dreams you just don't remember them, but if remembering is your goal start a SSRI.
Dopamine helps with pleasure, motivation, focus, reward, and mood. Dopamine's down side is psychomotor activation and aggravation of psychosis so schizophrenia patients should avoid it.
Norepinephrine helps with alertness, energy, mood, and believe it or not anxiety. Norepinenephrine's down side is tremor, tachycardia, dry mouth, and insomnia.
Wellbutrin has two transmitter reuptake inhibitors which both help with mood. For depressed people with anxiety caused by depression, this really helps.
Biggest factor about Wellbutrin is that many doctors use it with a SSRI to get even better results for treatment resistant depressed people.
Remember that with Effexor and Cymbalta that is it. There is no effective dopamine reuptake inhibitor being used as an add on. Also now Wellbutrin is now once a day so when combine with a once a day SSRI..treatment is all day.
Hey Wellbutrin is not the end all be all of AD's either. REMEMBER the American Psychiatric Assoc. states all anti depressants work equally well. Remission rates are basically the same.
> Manipulating SE and NE is such a broad and diverse area of research. Your dismissive statement of "just manipulating SE and NE" seems to conclude that any research into these two neurotransmitters is a failed avenue of research. Wrong.
>
> For one, duloxetine has much lower K(i) values, which indicates it prevents re-uptake much more potently than Effexor, in vivo. Furthermore, it takes a lot less of it to do so, as indicated by much lower ED-50 values. Finally, it prevents re-uptake of NE at much lower dosage levels than Effexor. The clincal trial data is also promising, but I'm not going to reiterate that here. My prediction: You're going to come back with a mea culpa in 6-9 months, and be happy to do so.
Posted by JLM on December 12, 2003, at 3:30:33
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on July 21, 2003, at 13:44:22
> Manipulating SE and NE is such a broad and diverse area of research. Your dismissive statement of "just manipulating SE and NE" seems to conclude that any research into these two neurotransmitters is a failed avenue of research. Wrong.
>
> For one, duloxetine has much lower K(i) values, which indicates it prevents re-uptake much more potently than Effexor, in vivo. Furthermore, it takes a lot less of it to do so, as indicated by much lower ED-50 values. Finally, it prevents re-uptake of NE at much lower dosage levels than Effexor. The clincal trial data is also promising, but I'm not going to reiterate that here. My prediction: You're going to come back with a mea culpa in 6-9 months, and be happy to do so.
Here's my mea culpa my friend ;)"Lilly believed the original Prozac patent held in the United States until December 2003. But in the week ending August 12th, an appellate court ruled competitors could begin to produce generic versions of fluoxetine from February 2001. Lilly’s stock fell from a capitalization of $123 billion to $85 billion, making it vulnerable to takeover. Suddenly it had considerable incentive to settle all cases and to prepare to trash Prozac and the generic fluoxetines that would appear in 2001, making way for the new improved molecule they hoped to launch in 2003. Zettler and Vickery applied between them to depose Teicher, Beasley, and a series of Lilly lawyers, including Doug Norman, who had been present in Hawaii. Teicher, extraordinarily, would be deposed effectively as a Lilly scientist and Beasley was to be quizzed about the clinical trials program for the new compound, in particular about what steps were being taken to determine its suicide potential.
Then, in October 2000, Lilly shelved its development plans for R-fluoxetine (Zalutria). The investigation of the cardiac profile of dextra-fluoxetine suggested that the company might not get the new drug to market in time to forestall the competition.40 Sepracor’s stock plummeted by 25%.41 Lilly was left with only duloxetine, a 1980s serotonin and norepinephrine reuptake inhibitor, in its antidepressant pipeline.42
I had first been approached about participating in a clinical trial of duloxetine in the early 1990s, before the company shelved the compound, as far as I knew because of bladder side effects. US psychopharmacologists dutifully praised the development that duloxetine constituted. But, probably unbeknownst to many of these experts, duloxetine had since been developed as a bladder stabilizer in many countries. Rebranding it as an antidepressant would raise interesting questions about duloxetine, not only among bladder specialists who knew nothing about its history as an antidepressant but also in the general public as well, who might well be mystified as to how a drug could be marketed for one condition in one country and an entirely different condition in others."
So, we are getting a drug that was shelved in the early 90's as an AD, and then subsequently marketed in other countries as a bladder stabilizer? Wow, Eli Lilly I'm really impressed!
Since r-fluoxetine went south, they NEED something
to keep them in the AD market. So what do they do? Pull out a drug that they themselves shelved (could that perhaps be because their own investigators didn't even think too much of it), put a new spin on the data, and get it to market.And the story about Teicher is just plain fascinating but that's another thread.
Posted by pseudonym on December 13, 2003, at 20:28:35
In reply to Re: Cymbalta/Duloxetine timing » pseudonym, posted by JLM on December 12, 2003, at 3:30:33
There is nothing in that article which contravenes the clinical data for duloxetine.
Also, molecules originally developed for DX A are later found to work for DX B, nothing suspicious there.
I'll get a genuine mea culpa from you yet.
Posted by JLM on December 14, 2003, at 2:12:14
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on December 13, 2003, at 20:28:35
> There is nothing in that article which contravenes the clinical data for duloxetine.
>
> Also, molecules originally developed for DX A are later found to work for DX B, nothing suspicious there.
>
> I'll get a genuine mea culpa from you yet.
>Well, if it was/IS so much better than fluoxetine, why'd they shelve it in the early 90's? Its been brought back to life, not because its any better, but because fluoxetine is now off patent, and r-fluoxetine was a bomb. A multimillion dollar bomb at that.
Its purely financial, just like Lexapro.
Posted by pseudonym on December 14, 2003, at 3:00:57
In reply to Re: Cymbalta/Duloxetine timing, posted by JLM on December 14, 2003, at 2:12:14
In the 52 week duloxetine study, the baseline HAMD-17 averaged 22.46. By week 52, that average had plummetted to 5.04. Show me any Escitalopram, Citalopram or Fluoxetine study anywhere with that kind of improvement. The financial incentive will always be there (I agree with your point on Lexapro). Have some faith, my friend.
Posted by JLM on December 14, 2003, at 4:13:44
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on December 14, 2003, at 3:00:57
Who conducted the 52 weeks study? Do you have any more details. I'd like to read that.
These types of claims have been made before, for instance with Effexor, and they later proved to be not true.
I don't think one single study is good enough. I'd like to read it, see WHO did (which at this point is more important than ever), and see the methodology.
There was an article in the British press recently that pointed out that about 50 percent of articles are pharmacotherapy are now ghostwritten. Interesting.
Now, the results you have cited may well be valid, I don't know, but that still doesn't answer the question as to why the drug was shelved in the first place, or why they waited for fluoxetine to go off patent, or why they went with r-fluoxetine first, and only pulled this out when it was clear that r-f wasn't going to fly. If the drug is really that supieror to everything else, why wait over a decade to bring it to market? Why not bring
it out in the early 90's and just totally slay your competition?
Posted by pseudonym on December 14, 2003, at 13:18:07
In reply to Re: Cymbalta/Duloxetine timing » pseudonym, posted by JLM on December 14, 2003, at 4:13:44
The article which outlines the 52 week duloxentine study is available in the October 2003 edition of the Journal of Clincal Psychiatry. Furthermore, the same article is also available at http://www.psychiatrist.com/privatepdf/2003/v64n10/v64n1015.pdf.
The site is not freely available, as if often the case with scientific journals, but in the off chance you subscribe, there you go.And as far as a single study is concerned, more exist. There are 6-7 other duloxetine studies available on the site as well.
Posted by lansolut on December 14, 2003, at 19:55:09
In reply to Re: Cymbalta/Duloxetine timing » pseudonym, posted by JLM on December 14, 2003, at 4:13:44
Forget Cymbalta. Watching you guys argue is so entertaining that I've forgotten to be depressed!
> Who conducted the 52 weeks study? Do you have any more details. I'd like to read that.
>
> These types of claims have been made before, for instance with Effexor, and they later proved to be not true.
>
> I don't think one single study is good enough. I'd like to read it, see WHO did (which at this point is more important than ever), and see the methodology.
>
> There was an article in the British press recently that pointed out that about 50 percent of articles are pharmacotherapy are now ghostwritten. Interesting.
>
>
> Now, the results you have cited may well be valid, I don't know, but that still doesn't answer the question as to why the drug was shelved in the first place, or why they waited for fluoxetine to go off patent, or why they went with r-fluoxetine first, and only pulled this out when it was clear that r-f wasn't going to fly. If the drug is really that supieror to everything else, why wait over a decade to bring it to market? Why not bring
> it out in the early 90's and just totally slay your competition?
>
>
Posted by JLM on December 14, 2003, at 20:36:46
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on December 14, 2003, at 13:18:07
Okay, without having read the actual study but just some summaries, am I correct to assume that there was no comparitor substance? IE, no placebo comparison or comparison to an older agent.
If that's the case, then the results really don't mean all that much to me.
Do any of these other studies, ie the 6-7 you mentioned show the same results as the open label study?
Posted by HIBA on December 16, 2003, at 0:36:51
In reply to Re: Cymbalta/Duloxetine timing, posted by JLM on December 14, 2003, at 20:36:46
Hi Guys,Why are you so nervous about cymbalta? What is so special about it? Whenever drug hits the market enthusiam goes high to the everest, only to understand later there is nothing new in it. Go to hell my damned pessimism. But I have learned to be too pessimistic over medications. There is no drug I didn't try in my life. Recently zoloft which helped a bit even in the sexul area. But alas! I am my old self again.
More than fifty years of intensive research hasn't made our depressive's life any better. We are left alone with our sufferings. When one drug helps soon sexual side effects curtain those good effects. An antidepressant without sexual side effects is what we patients need. Will there be any?
HIBA
Posted by JLM on December 16, 2003, at 0:43:34
In reply to Re: What is so special about cymbalta?, posted by HIBA on December 16, 2003, at 0:36:51
HIBA,
I totally can relate to how you feel, trust me. 50 years, and very little real progress has made. That's why I'm skeptical about Cymbalta. I doubt it will be any better than anything we've seen before.
I got some inside info about why it was shelved the first time. It causes urinary retention. In fact, it apparently causes it so well, that its been on the market in Sweden for many years now as a bladder stabilizer.
Wow, Lilly, is that the best you can do?
My sources opinion was, and I quote, "This is Eli Lilly scraping the bottom of the barrel".
Posted by SLS on December 16, 2003, at 8:41:31
In reply to Re: What is so special about cymbalta? » HIBA, posted by JLM on December 16, 2003, at 0:43:34
> My sources opinion was, and I quote, "This is Eli Lilly scraping the bottom of the barrel".One person's bottom of the barrel might be another's cream of the crop.
I've got my fingers crossed that duloxetine comes out sooner than later. As long as it's safe, what would be so terrible if it were to be approved by the FDA? I don't know. Perhaps it would encourage Lilly to sacrifice the R&D of other drugs?
- Scott
Posted by JLM on December 16, 2003, at 8:52:57
In reply to Re: What is so special about cymbalta?, posted by SLS on December 16, 2003, at 8:41:31
Scott, don't you want something that is safe, and effective? Or just safe?
This is interesting too:
http://www.guardian.co.uk/medicine/story/0,11381,1101706,00.html
Posted by SLS on December 16, 2003, at 9:10:09
In reply to Re: What is so special about cymbalta? » SLS, posted by JLM on December 16, 2003, at 8:52:57
> Scott, don't you want something that is safe, and effective? Or just safe?
I want something that is both safe and effective for ME. If duloxetine only helps 25% of people, and I am one of them, that's reason enough for me to want it approved. I don't know why anyone would want to prevent any new drug to be approved unless doing so somehow impacts negatively the development of still newer drugs.
- Scott
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