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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by jealibeanz on February 14, 2007, at 17:27:41
The company (makers of Ambien, many vaccines, and other population drugs) has released information about its current sales and pipeline drugs.
If you scroll down to page 118, it has a section on the anxiety/depression drugs... especially the 2 that are in advanced phases of stage 3.
Unfortunately, it seems like these are years away from being considered for approval. Maybe I'm wrong, since I don't understand the process very well. Can someone take a look at in a tell me what they think in terms of a timeline?
http://en.sanofi-aventis.com/Images/070213_EN_V13avec_annexes_tcm24-15951.pdf
Posted by Larry Hoover on February 14, 2007, at 18:56:00
In reply to Sanofi-Aventis Progress Report, posted by jealibeanz on February 14, 2007, at 17:27:41
> Unfortunately, it seems like these are years away from being considered for approval. Maybe I'm wrong, since I don't understand the process very well. Can someone take a look at in a tell me what they think in terms of a timeline?
Saredutant looks like its further along than Amibegron; at least the clinical trials have been registered with the FDA for the former drug. I think three years for Saredutant would be optimistic, but I could be wrong. The other drug hasn't yet got a registered Phase III trial, so I think it will be somewhat later still.
One way to get your hands on these drugs earlier is to get in on the clinical trials (and hope you're not placeboed). See: http://www.clinicaltrials.gov/ct/search;jsessionid=98672C64E5368005AF7ACA475C45AC74?term=saredutant&submit=Search
Lar
Posted by jealibeanz on February 14, 2007, at 19:34:27
In reply to Re: Sanofi-Aventis Progress Report » jealibeanz, posted by Larry Hoover on February 14, 2007, at 18:56:00
> > Unfortunately, it seems like these are years away from being considered for approval. Maybe I'm wrong, since I don't understand the process very well. Can someone take a look at in a tell me what they think in terms of a timeline?
>
> Saredutant looks like its further along than Amibegron; at least the clinical trials have been registered with the FDA for the former drug. I think three years for Saredutant would be optimistic, but I could be wrong. The other drug hasn't yet got a registered Phase III trial, so I think it will be somewhat later still.
>
> One way to get your hands on these drugs earlier is to get in on the clinical trials (and hope you're not placeboed). See: http://www.clinicaltrials.gov/ct/search;jsessionid=98672C64E5368005AF7ACA475C45AC74?term=saredutant&submit=Search
>
> LarWell... if you look at this site, SR 58611 has asupplemental NDA possible in 2007. So I'm confused.
Posted by jealibeanz on February 14, 2007, at 19:40:01
In reply to Re: Sanofi-Aventis Progress Report » jealibeanz, posted by Larry Hoover on February 14, 2007, at 18:56:00
> > Unfortunately, it seems like these are years away from being considered for approval. Maybe I'm wrong, since I don't understand the process very well. Can someone take a look at in a tell me what they think in terms of a timeline?
>
> Saredutant looks like its further along than Amibegron; at least the clinical trials have been registered with the FDA for the former drug. I think three years for Saredutant would be optimistic, but I could be wrong. The other drug hasn't yet got a registered Phase III trial, so I think it will be somewhat later still.
>
> One way to get your hands on these drugs earlier is to get in on the clinical trials (and hope you're not placeboed). See: http://www.clinicaltrials.gov/ct/search;jsessionid=98672C64E5368005AF7ACA475C45AC74?term=saredutant&submit=Search
>
> LarI'd have to give up my Xanax and Lunesta just to be considered...
Posted by Larry Hoover on February 14, 2007, at 20:18:05
In reply to Re: Sanofi-Aventis Progress Report » Larry Hoover, posted by jealibeanz on February 14, 2007, at 19:34:27
> Well... if you look at this site, SR 58611 has asupplemental NDA possible in 2007. So I'm confused.
>
> http://www.neurotransmitter.net/newdrugs.htmlThis particular compound has been around for about twenty years, and has already gone through phase I and II trials. By using a supplemental application, they only need to show efficacy for a new indication, e.g. depression, rather than the original NDA which was for irritable bowel syndrome. Makes you wonder what the side effects of this one might be, as there are two kinds of IBS.....diarrhea predominant and constipation predominant (as well as one that alternates, which some argue is a variant of the constipation predominant). Anyway, I digress.
Lar
Posted by Larry Hoover on February 14, 2007, at 20:22:49
In reply to Re: Sanofi-Aventis Progress Report » Larry Hoover, posted by jealibeanz on February 14, 2007, at 19:40:01
> > One way to get your hands on these drugs earlier is to get in on the clinical trials (and hope you're not placeboed). See: http://www.clinicaltrials.gov/ct/search;jsessionid=98672C64E5368005AF7ACA475C45AC74?term=saredutant&submit=Search
> >
> > Lar
>
> I'd have to give up my Xanax and Lunesta just to be considered...Ya. I hear you.
However, it shows some of the difficulty in finding subjects for these trials, why they often take much longer than projected, and raises issues about whether the trial subjects are even representative of the population for whom the drugs are supposedly meant to treat.
Lar
Posted by jealibeanz on February 14, 2007, at 20:30:39
In reply to Re: Sanofi-Aventis Progress Report » jealibeanz, posted by Larry Hoover on February 14, 2007, at 20:18:05
> > Well... if you look at this site, SR 58611 has asupplemental NDA possible in 2007. So I'm confused.
> >
> > http://www.neurotransmitter.net/newdrugs.html
>
> This particular compound has been around for about twenty years, and has already gone through phase I and II trials. By using a supplemental application, they only need to show efficacy for a new indication, e.g. depression, rather than the original NDA which was for irritable bowel syndrome. Makes you wonder what the side effects of this one might be, as there are two kinds of IBS.....diarrhea predominant and constipation predominant (as well as one that alternates, which some argue is a variant of the constipation predominant). Anyway, I digress.
>
> LarYeah, I knew about its use for IBS... and side effects... which are many.... but there's always many side effects for any drug. So who knows.
Posted by Phillipa on February 14, 2007, at 21:37:01
In reply to Re: Sanofi-Aventis Progress Report, posted by jealibeanz on February 14, 2007, at 20:30:39
Is it true that in a drug trial when it's over you have to give up the med even if it's working? Love Phillipa
Posted by notfred on February 14, 2007, at 23:39:56
In reply to Re: Sanofi-Aventis Progress Report, posted by Phillipa on February 14, 2007, at 21:37:01
"Is it true that in a drug trial when it's over you have to give up the med even if it's working?"
Sometimes you cannot contine, sometimes you can continue with the drug. If the drug is not going to make it to market you will not be able to continue the drug. Some people stick to doing only late stage testing; drugs are more likely to make it to market if they make it to late stage testing. You may or may not be able to continue the med between the time the study ends and the drug hits the market.This is all disclosed to study subjects up front.
Posted by yxibow on February 17, 2007, at 3:21:26
In reply to Re: Sanofi-Aventis Progress Report, posted by notfred on February 14, 2007, at 23:39:56
> "Is it true that in a drug trial when it's over you have to give up the med even if it's working?"
>
>
> Sometimes you cannot contine, sometimes you can continue with the drug. If the drug is not going to make it to market you will not be able to continue the drug. Some people stick to doing only late stage testing; drugs are more likely to make it to market if they make it to late stage testing. You may or may not be able to continue the med between the time the study ends and the drug hits the market.
>
> This is all disclosed to study subjects up front.
There is also compassionate / orphan use of continuation, for say late stage oncology medication. So the purpose depends alot. Since cancer medications can have improvement rates as low as 10%, if you are among the lucky who are improving with the medication, there may be something that the drug company can do between itself and the FDA.
This is the end of the thread.
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