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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 116. This is the beginning of the thread.
Posted by Jack Smith on March 11, 2003, at 12:55:39
There has got to be something going on with duloxetine that we just don't know about. I mean they got an approvable letter almost six months ago and knowing Lily's eagerness to get the stuff out, you think it would be here by now. I CANNOT believe that their manufacturing problems are that great. I mean Straterra is here which is also manufactured by Lily. Something is going on. Moreover, apparently Lily is asking for more volunteers to do more clinical trials for depression with cymbalta. I think this drug won't be out for a while, unfortunately. I hope I am wrong.
So many times people get their hopes up. If you look through the archives, you will see posts saying that reboxetine would be out by the end of 1999! Now, we know it's never coming out. Also, you will see posts in 2000 saying that the selegiline patch will be out by the end of that year. Last I heard, someone here talked to Dr. Bodkin who said that he would bet it would be out by this time next year. I would take that bet in a heartbeat. . . . . I have high hopes for cymbalta but looks like I am going to just go with effexor--which seems to be a little less potent than duloxetine and because of its shorter half life almost postively has worse withdrawls.
Just my two cents. Thanks for listening.
JACK
Posted by jrbecker on March 11, 2003, at 13:25:22
In reply to Cymbalta/Duloxetine--Something's Up, posted by Jack Smith on March 11, 2003, at 12:55:39
I have spoken to Bodkin myself, and yes, he did state his belief that the selegiline patch will be on the market within a year from now. This is a prediction I assume to be true.
As for Duloxetine, I do indeed believe it is the current interaction with the FDA that is holding it up. This is of course speculation, but many assume this is the case.
http://www.thestreet.com/_yahoo/tech/adamfeuerstein/10064207_2.html
I still believe it is on track to make final approval in less than 6 months. Just my guess.
In the end, it's never worth it to hype these drugs until they get on the market anyways. It's good to hope though, isn't it.
JRB
> There has got to be something going on with duloxetine that we just don't know about. I mean they got an approvable letter almost six months ago and knowing Lily's eagerness to get the stuff out, you think it would be here by now. I CANNOT believe that their manufacturing problems are that great. I mean Straterra is here which is also manufactured by Lily. Something is going on. Moreover, apparently Lily is asking for more volunteers to do more clinical trials for depression with cymbalta. I think this drug won't be out for a while, unfortunately. I hope I am wrong.
>
> So many times people get their hopes up. If you look through the archives, you will see posts saying that reboxetine would be out by the end of 1999! Now, we know it's never coming out. Also, you will see posts in 2000 saying that the selegiline patch will be out by the end of that year. Last I heard, someone here talked to Dr. Bodkin who said that he would bet it would be out by this time next year. I would take that bet in a heartbeat. . . . . I have high hopes for cymbalta but looks like I am going to just go with effexor--which seems to be a little less potent than duloxetine and because of its shorter half life almost postively has worse withdrawls.
>
> Just my two cents. Thanks for listening.
>
> JACK
Posted by Jack Smith on March 11, 2003, at 16:39:19
In reply to Re: Cymbalta/Duloxetine--Something's Up, posted by jrbecker on March 11, 2003, at 13:25:22
> I have spoken to Bodkin myself, and yes, he did state his belief that the selegiline patch will be on the market within a year from now. This is a prediction I assume to be true.
I am sure that Dr. Bodkin is optimistic and I hope he is correct but I am still not holding my breath. Check out this thread from 1999!
http://www.dr-bob.org/babble/19991001/msgs/12585.html
and we are still waiting!! How do you know Bodkin? Have you asked him about the possibility of using other drugs in patches, particularly other MAOI's?
> As for Duloxetine, I do indeed believe it is the current interaction with the FDA that is holding it up. This is of course speculation, but many assume this is the case.I am just a little skeptical. I called Lily today and they still have not opened up recruitment for a ONE YEAR study. Obviously, the drug can go to market before the study is out. I am just wondering why they would want to fund a study for duloxetine for depression after they get approval from the FDA for this indication.
I am still optimistic. I would just rather try Cymbalta than Effexor (longer half life) and would much rather try selegeline patch to nardil or parnate.
JACK
Posted by SLS on March 11, 2003, at 20:27:46
In reply to Re: Cymbalta/Duloxetine--Something's Up, posted by jrbecker on March 11, 2003, at 13:25:22
Hi y'all.
I spoke to Lilly earlier today. Their marketing representative cooraborated what I had heard or read previously. The FDA is holding up approval of duloxetine pending evaluation of their manufacturing process. There are no issues regarding labelling. Lilly was granted an approvable letter by the FDA in September. This means that safety and efficacy have been firmly established in their estimation. It sure is taking a long time.
- Scott
Posted by Ritch on March 11, 2003, at 23:12:55
In reply to Re: Cymbalta/Duloxetine--Something's Up, posted by SLS on March 11, 2003, at 20:27:46
> Hi y'all.
>
> I spoke to Lilly earlier today. Their marketing representative cooraborated what I had heard or read previously. The FDA is holding up approval of duloxetine pending evaluation of their manufacturing process. There are no issues regarding labelling. Lilly was granted an approvable letter by the FDA in September. This means that safety and efficacy have been firmly established in their estimation. It sure is taking a long time.
>
>
> - Scott
>
>
Scott, just a thought here, but maybe Lilly isn't in any really big hurry to get Cymbalta on the shelves while many are working through their Lexapro trials. They might do better by sitting on the sidelines for a few extra months while everyone goes through the Lex trials and then spring it when docs and patients have reached some firm conclusions about Lex's effectiveness/tolerability. IOW, it isn't going to help to burn money/time to get it to market more quickly..
Posted by BekkaH on March 11, 2003, at 23:29:38
In reply to Re: Cymbalta/Duloxetine--Something's Up » SLS, posted by Ritch on March 11, 2003, at 23:12:55
Ritch, Lexapro is made by Forest Labs. Lilly makes Cymbalta and Strattera, etc.
Posted by Ritch on March 12, 2003, at 9:56:51
In reply to Lexapro is not from Lilly - Ritch, posted by BekkaH on March 11, 2003, at 23:29:38
> Ritch, Lexapro is made by Forest Labs. Lilly makes Cymbalta and Strattera, etc.
>Hi Bekka, yes that is *precisely* why I mentioned that. I didn't explain my reasoning very well. I know Lilly is losing *some* money short term by having mfg. problems and delaying the introduction. But I was wondering about the *timing* of the introduction perhaps being more important for Lilly. They are aware that Forest has released Lexapro and many are being switched to it and trying it for the first time. As with many other AD's it is going to poopout for a significant minority of folks on it or after a few months not seem to be as efficacious for others. That's when they will be ready to juggle meds again. I just wonder if some delay could benefit the introduction of Cymbalta because Lexapro will have been tried enough and docs will be more willing to make a switch *from* Lexapro to Cymbalta if the docs have had more experience with Lexapro beforehand.
Posted by jrbecker on March 12, 2003, at 20:38:48
In reply to Re: Cymbalta/Duloxetine--Something's Up » SLS, posted by Ritch on March 11, 2003, at 23:12:55
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.
Posted by BekkaH on March 12, 2003, at 21:33:40
In reply to Re: Lexapro is not from Lilly - Ritch, posted by Ritch on March 12, 2003, at 9:56:51
> > > Hi Bekka, yes that is *precisely* why I mentioned that.
Oh, now I see what you mean. Thanks for the explanation.
Posted by Ritch on March 12, 2003, at 23:17:01
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on March 12, 2003, at 20:38:48
Posted by hok on March 13, 2003, at 14:19:14
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on March 12, 2003, at 20:38:48
Posted by hok on March 14, 2003, at 11:03:23
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on March 12, 2003, at 20:38:48
so we can assume that means a mid-summer release, somewhere around July?
Posted by Jack Smith on March 14, 2003, at 12:23:20
In reply to Re: Cymbalta/Duloxetine timing, posted by hok on March 14, 2003, at 11:03:23
> so we can assume that means a mid-summer release, somewhere around July?
We can't assume anything with this. Selegiline Patch. Reboxetine. Ring any bells.
Posted by hok on March 14, 2003, at 12:46:53
In reply to Re: Cymbalta/Duloxetine timing, posted by Jack Smith on March 14, 2003, at 12:23:20
pessimmism ain't good for the mind Jack. Think positive my friend. Plus, basing Cymbalta's progress on the past woes of Selegiline patch and reboxetine isn't really logical. We can only go with the info we've been given thus far, and right now it points to a summer release.
> > so we can assume that means a mid-summer release, somewhere around July?
>
> We can't assume anything with this. Selegiline Patch. Reboxetine. Ring any bells.
Posted by jrbecker on March 14, 2003, at 15:51:03
In reply to Re: Cymbalta/Duloxetine timing, posted by hok on March 14, 2003, at 12:46:53
Some of you mentioned that you are interested in being involved in a duloxetine trial. Unfortuantely, the big trial that's listed on the clinicaltrials.gov site is still not open yet. In talking to my doc, who has been involved in the Phase III trials, he mentioned that the best way to go about it is have your psychiatrist call in to the Lilly research line for you. There are supposedly trials going on that are not listed on websites. Just one more way you might be able to uncover a trial in your area.
-JRB
Posted by SLS on March 14, 2003, at 18:49:27
In reply to Re: Cymbalta/Duloxetine trials, posted by jrbecker on March 14, 2003, at 15:51:03
What about http://www.lillytrials.com/neuroscience/neuro_trials.shtml ?
Posted by hok on March 14, 2003, at 21:13:32
In reply to Re: Cymbalta/Duloxetine trials, posted by SLS on March 14, 2003, at 18:49:27
Thanks for posting this Scott. I think JRB is referring to an even larger study that has been posted on clinicaltrials.gov that has more sites than the one you listed. It includes a few more major cities and states...
Posted by jrbecker on April 8, 2003, at 19:55:31
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on March 12, 2003, at 20:38:48
The latest I've heard from the Lilly camp...August will be the month that duloxetine gets to market. Their manufacturing hold-ups are being resolved in the interim. All is going smoothly now supposedly. That's all I know, but the news is as recent as last Friday, April 4th.
JB
Posted by lansolut on April 14, 2003, at 19:03:55
In reply to Re: Cymbalta/Duloxetine timing, posted by jrbecker on April 8, 2003, at 19:55:31
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 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?
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