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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 23 of 23. This is the beginning of the thread.
Posted by jealibeanz on January 31, 2007, at 9:49:43
Has anyone heard any news about the upcoming depression/anxiety drugs in stage III by Sanodi-Aventis? There's an NK1 receptor antagonist and a beta-3 adrenoreceptor blocker. The later seems to be further along. Any word?
Posted by dbc on January 31, 2007, at 13:49:05
In reply to Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 9:49:43
>adrenoreceptor blocker
You have my interest mr beanz please explain more.
Posted by Tom Twilight on January 31, 2007, at 13:49:54
In reply to Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 9:49:43
Its not good news at the moment I fear :(
I don't know whats happened to Sarenductant, it sounded good
Posted by jealibeanz on January 31, 2007, at 13:55:30
In reply to Re: Updates on pipeline drugs?, posted by Tom Twilight on January 31, 2007, at 13:49:54
Well there is a planned NDA for the beta-3 drug, but I don't know how far away that means it will be.
Posted by halcyondaze on January 31, 2007, at 14:42:54
In reply to Re: Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 13:55:30
Saredutant is still in clinical trials in the US.
Agomelatine, a drug that works on melatonin, is also in clinical trials.
I vaguely heard something about triple reuptake inhibitors but as far as I know they haven't passed Phase I yet.
Posted by linkadge on January 31, 2007, at 17:09:09
In reply to Re: Updates on pipeline drugs?, posted by halcyondaze on January 31, 2007, at 14:42:54
I was under the impression that agomelatine was dropped (?)
Linkadge
Posted by halcyondaze on January 31, 2007, at 18:58:41
In reply to Re: Updates on pipeline drugs?, posted by linkadge on January 31, 2007, at 17:09:09
> I was under the impression that agomelatine was dropped (?)
>
> LinkadgeThat would be news to the research site I work for! :P
Posted by River1924 on January 31, 2007, at 23:02:52
In reply to Re: Updates on pipeline drugs?, posted by linkadge on January 31, 2007, at 17:09:09
Link,
I think the EU denied approval but it is still in trials for the US.
River.
Posted by River1924 on January 31, 2007, at 23:06:27
In reply to Re: Updates on pipeline drugs?, posted by halcyondaze on January 31, 2007, at 18:58:41
Posted by XanyADDam on February 1, 2007, at 2:51:14
In reply to Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 9:49:43
> Has anyone heard any news about the upcoming depression/anxiety drugs in stage III by Sanodi-Aventis? There's an NK1 receptor antagonist and a beta-3 adrenoreceptor blocker. The later seems to be further along. Any word?
Yeah...I checked out http://www.neurotransmitter.net/newdrugs.html. The drugs you were referring to, SR 58611 and Saredutant (SR 48968)...SR 58611 is a selective beta-3-adrenoceptor agonist, used to treat depression and anxiety. As far as its development phase: A supplemental NDA is possible in 2007. Saredutant, an NK2 antagonist, has been indicated in the treatment of depression and anxiety as well. It is, as you stated, currently in Phase III.
Posted by jealibeanz on February 1, 2007, at 4:15:01
In reply to Re: Updates on pipeline drugs? » jealibeanz, posted by XanyADDam on February 1, 2007, at 2:51:14
"Yeah...I checked out http://www.neurotransmitter.net/newdrugs.html. The drugs you were referring to, SR 58611 and Saredutant (SR 48968)...SR 58611 is a selective beta-3-adrenoceptor agonist, used to treat depression and anxiety. As far as its development phase: A supplemental NDA is possible in 2007. Saredutant, an NK2 antagonist, has been indicated in the treatment of depression and anxiety as well. It is, as you stated, currently in Phase III."
That is where I get my info from. I wondering where they get theirs from and wanted to know if anyone knew of anyupdates.The pharmaceutical websites a verrry behind, some almost a year. If contacted, they don't give out much information.
The FDA website has nothing to offer unless an NDA has been submitted.
Posted by rovers95 on February 3, 2007, at 14:56:07
In reply to Re: Updates on pipeline drugs?, posted by jealibeanz on February 1, 2007, at 4:15:01
On the net, it says some of these studies have been completed - does anyone know the results???? Is it worth gettin excited about???????!!!
mark
Posted by JohnnyBLinux on February 16, 2007, at 0:35:02
In reply to Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 9:49:43
Yes, I have heard. Saredutant (SR48968C) is in Phase III clinical trials.
I'm participating as a subject in a double-blind research study evaluating this investigational drug for GAD. So, I do NOT know if I'm taking active drug or placebo.
sanofi-aventis must be close to entering the last phase. Time will tell if Saredutant receives FDA approval.
Posted by jealibeanz on February 16, 2007, at 1:01:43
In reply to Re: Updates on pipeline drugs?, posted by JohnnyBLinux on February 16, 2007, at 0:35:02
> Yes, I have heard. Saredutant (SR48968C) is in Phase III clinical trials.
>
> I'm participating as a subject in a double-blind research study evaluating this investigational drug for GAD. So, I do NOT know if I'm taking active drug or placebo.
>
> sanofi-aventis must be close to entering the last phase. Time will tell if Saredutant receives FDA approval.How long have you been taking it? Do you feel a difference? What other meds have you tried? How long do you think it'll be before it gets approved?
Posted by randermin on February 16, 2007, at 9:52:36
In reply to Re: Updates on pipeline drugs?, posted by linkadge on January 31, 2007, at 17:09:09
> I was under the impression that agomelatine was dropped (?)
>
> Linkadgegod I hope not, agomelatine sounds like a magic bullet for me. that or gaboxadol...
Posted by jealibeanz on February 16, 2007, at 13:51:25
In reply to Re: Updates on pipeline drugs?, posted by randermin on February 16, 2007, at 9:52:36
> > I was under the impression that agomelatine was dropped (?)
> >
> > Linkadge
>
> god I hope not, agomelatine sounds like a magic bullet for me. that or gaboxadol...What kind of drugs are those? Who makes it? What's the mechanism?
Posted by randermin on February 17, 2007, at 12:23:39
In reply to Re: Updates on pipeline drugs?, posted by jealibeanz on February 16, 2007, at 13:51:25
I dont know anything about agomelatine, its got a sleep promting angle to it i think. but gaboxadol is supposed to be a sleeping pill that promotes slow wave sleep, the only other thing like that is xyrem, which I guess is dangerous so no one ever gets it.
Posted by River1924 on February 17, 2007, at 13:30:38
In reply to Re: Updates on pipeline drugs?, posted by jealibeanz on February 16, 2007, at 13:51:25
After decades of treading water, Big Pharma appears to be making progress in the search for better treatments for depression.
Midstage human testing of new drugs, which attack the mood disorder in different ways, is already under way. Companies from Pfizer Inc. to Sanofi-Aventis are targeting a system of brain chemicals that are involved in the body's response to stress. Also showing potential are drugs that block the brain's pain, sleep and nicotine receptors, and could also influence mood.
Any advances would be welcomed by patients and industry alike. Depression, which has both physical and mental symptoms, affects about one in 10 adult Americans each year. Existing treatments work in only about half of patients, can have unpleasant side effects and have come under fire for possible links to suicidal thoughts. They nonetheless generated more than $12.6 billion in sales for the industry last year, according to the health-care information company Verispan. But drug makers stand to lose a big chunk of that revenue as many of the best-sellers lose patent protection.
The current crop of antidepressants, from the old standby Prozac to the brand-new Cymbalta, largely function the same way. They target a system of neurotransmitters, including the well-known serotonin, by correcting an imbalance that can take place in a small part of the brain. Doctors stumbled on the system's connection to mood in the 1950s while treating tuberculosis, and it has dominated industry thinking ever since.
"It's rather amazing to consider that even with the tremendous amount of research that has been done on depression, existing medications act on proteins from only about 20 of the approximately 15,000 genes in the brain," says Jack Grebb, vice president of neuroscience global clinical research at Bristol-Myers Squibb Co.
That reality pushed doctors toward new thinking. "As a resident, you have a textbook knowledge that antidepressants need two or three weeks to work," says Florian Holsboer, a professor of psychiatry and a director of the Max Planck Institute of Psychiatry in Munich. "I was very disappointed with that in reality and was scratching my head to rethink ideas about the causality of depression." Dr. Holsboer has been working on the stress approach to antidepressant drugs since the 1980s.
Taking on new approaches is clearly risky for pharmaceutical companies. Tinkering with serotonin-based antidepressants is easier for drug makers, and regulatory approval is more predictable. In 2003, Merck & Co. abandoned its study of a drug that was thought to affect mood by blocking a receptor linked to pain. It had failed efficacy tests after about 10 years of research.
Part of the problem is that the biology of depression isn't well understood, even compared with other difficult psychiatric diseases. Animal tests can be inconclusive; after all, scientists can't ask a rat if it feels sad. But small studies, and then slightly larger investigations, have given rise to new ideas about how depression works and how it might be treated.
For instance, there's a growing awareness at the molecular level that stress causes the increased production of a protein called CRF, which in turn triggers the release of hormones, including cortisol. Researchers now believe that excess cortisol can predispose people to depression by damaging nerve-cell connections and suppressing nerve growth.
Blocking the action of CRF on its target, CRF1, could help regulate that imbalance. Bristol-Myers Squibb has a so-called CRF1 antagonist in the middle stages of testing. GlaxoSmithKline PLC, Pfizer, Sanofi-Aventis and Johnson & Johnson are in the earlier stage of human testing on CRF1 drugs.
Vasopressin, a protein like CRF, can also increase cortisol, though more indirectly. Sanofi-Aventis and Wyeth are testing vasopressin antagonists, forms of which were originally developed to fight high blood pressure and heart failure.
Some scientists view depression as a form of emotional pain. That view led Merck to research a drug to act on the receptor NK1, which is involved in the transmission of pain messages among the brain's neurons. When the drug it developed failed to work on depression, researchers from other drug companies turned to the related receptors NK2 and NK3 to see if they also had behavioral effects. Sanofi is now in the final phase of human testing on an antagonist to the NK2 receptor, which researchers think can play a role in emotional behavior and the brain's ability to adjust.
Novartis AG has U.S. rights to a drug, called agomelatine, which is thought to influence mood in part through the sleep-wake cycle. This summer, European Union drug officials declined to approve the drug without long-term data showing its effectiveness. Novartis is optimistic about its regulatory chances in the U.S.; Servier, which has the EU rights to the drug, is collecting more data and plans to resubmit the drug.
In addition to agomelatine, Novartis has a drug in the early stages of human testing that could help regulate pat of a major system of neurotransmitters in charge of excitability. That system accounts for nearly half of the neurotransmitters in the brain, but it has only recently become a target for serious drug development because drugs that aren't sufficiently nuanced risk causing seizures or loss of consciousness, says Gerard Sanacora, head of the Depression Research Program at Yale Medical School, who is conducting research on depression and that system, called the glutamate system.
The Novartis drug, in particular, targets the system's metabatropic glutamate receptor 5, which scientists think plays a role in the body's ability to react and adapt and thus is linked to people's response to stress. The drug in development would slow down the overactive response that is thought to exist in some depressed patients.
Meanwhile, smaller pharmaceutical companies are going after novel neurological pathways with older drugs that are thought to work on depression in new ways. Corcept Therapeutics Inc. is studying the effects of the abortion pill, mifepristone, on psychotic depression. The drug is believed to help the body reduce the effects of the elevated and abnormal release patterns of the hormone cortisol that can occur in psychotic depression. But in September the pill failed to beat an antidepressant alone in a Phase III study.
Targacept Inc. just finished a midstage study showing that mecamylamine, an old blood-pressure drug it got from Merck, acts as an antidepressant by working in a way that's related to nicotine addiction in the brain. Just as the nicotine in tobacco can improve a smoker's mood, a nicotine patch can make depressed patients feel better. The idea behind the drug is that blocking the brain's nicotinic receptors will control mood fluctuations.
For now, the CRF1 antagonists seem closest to commercialization. P. Murali Doraiswamy, head of the biological psychiatry division at Duke University, put the chances of CRF1 drugs making it to market at 30 percent.
CRF1 drugs could still run into some of the hurdles that earlier novel antidepressants faced. Several drug companies have canceled their CRF1 programs, in part because the drug can cause liver toxicity in early tests, among other problems. Bristol-Myers, for example, tabled one of its two CRF1 compounds recently in favor of the one it now has in human testing, and Johnson & Johnson abandoned one of its programs.
Scientists are cautiously optimistic, though. "If even one of these novel drugs makes it to the market, it would be a breath of fresh air for the field," Dr. Doraiswamy says.
Posted by jealibeanz on February 17, 2007, at 14:57:06
In reply to Re: Updates on pipeline drugs?, posted by River1924 on February 17, 2007, at 13:30:38
It's nice to see an entire article addressing the need for new drugs.
I'm not certain, but I think that the Corcept drug is supposed to be approved to psychotic depression if the next studies go well. It was granted a "fast track" by the FDA, since there's not much right now that helps with psychosis.
I don't know if this article was saying its failure was in reference to major depression, or its primary intended use, psychotic depression. The company does intend to get it approved for other uses, but the focus for now is psychosis.
It seems that it should work well on anxious depression, since excess cortisol can cause anxiety. But that's not even listed as a possible future use on their website.
Posted by Ken Blades on February 18, 2007, at 4:35:23
In reply to Updates on pipeline drugs?, posted by jealibeanz on January 31, 2007, at 9:49:43
Just read this news release re Sanofi-Aventis drug:
Posted by jealibeanz on February 18, 2007, at 6:37:24
In reply to Re: Updates on pipeline drugs? » jealibeanz, posted by Ken Blades on February 18, 2007, at 4:35:23
> Just read this news release re Sanofi-Aventis drug:
>
> http://www.in-pharmatechnologist.com/news/ng.asp?n=74203-sanofi-aventis-menarini-astrazeneca-tachykinin-depression
>
>Nice article. How did you get to read the full versions, rather than the abstracts, without paying?
Posted by Ken Blades on February 18, 2007, at 8:10:38
In reply to Re: Updates on pipeline drugs? » Ken Blades, posted by jealibeanz on February 18, 2007, at 6:37:24
Don't really know why...when you 'land' on some
articles or references to them, you can read
the whole thing and sometimes you can't. I've
registered for New England Journal of Medicine,
where you can read articles that are older than
six months.Here are some links to some articles...you may
be able to search the sites of each to see if
there are things you'd be interested in:http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=EBI&pubmedid=16532386
http://ajp.psychiatryonline.org/cgi/content/full/157/10/1606
http://www.pnas.org/cgi/reprint/99/26/17113
[then click on 'begin manual download']http://ajp.psychiatryonline.org/cgi/reprint/161/1/59
[then click on 'manual download']http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1424685&blobtype=pdf
Search:
http://neuro.psychiatryonline.org/search.dtl
http://www.pnas.org/search.dtl
http://archpsyc.ama-assn.org/cgi/content/full/62/2/190
[you can register as a guest...then get articles
12 months old and older]http://www.sciencemag.org/subscriptions/indiv_register.dtl
[if you register you can get research articles
12 months back to 1996]
Posted by JohnnyBLinux on March 3, 2007, at 0:23:02
In reply to Re: Updates on pipeline drugs?, posted by jealibeanz on February 16, 2007, at 1:01:43
> > Yes, I have heard. Saredutant (SR48968C) is in Phase III clinical trials.
> >
> > I'm participating as a subject in a double-blind research study evaluating this investigational drug for GAD. So, I do NOT know if I'm taking active drug or placebo.
> >
> > sanofi-aventis must be close to entering the last phase. Time will tell if Saredutant receives FDA approval.
>
>
> How long have you been taking it? Do you feel a difference? What other meds have you tried? How long do you think it'll be before it gets approved?
>
>
Hmm, I want to say that I'm nearly done with the 5th week of the research study for "Saredutant". A double-blind experiment means neither me nor the study doctor know if I'm taking the active substance or placebo. So, please take my response with a grain of salt for good measure.Honestly, I don't feel different. There's been subtle changes, such as less teeth grinding and restlessness. I've tried other medications in the past. In my experience, the most effective have been Adderall and Dexedrine tablets, but I don't think they are frequently prescribed for depression or anxiety. I took them for another condition. Right now I take Ritalin 10mg 3x / day which works well but has little impact on mood. Antidepressants, like Paxil or Zoloft, often made me feel weird, and I can't recall if they helped. To answer your other question, I don't know if or when "Saredutant" will be approved.
This is the end of the thread.
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