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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by Tom on March 5, 2000, at 22:11:48
ive heard that approval of reboxetine is being held up...by the FDA....could it be that their affraid it might cut into sales profits of american drugs like say prozac.....its all about money...not saftey
Posted by dove on March 6, 2000, at 8:44:13
In reply to reboxetine, posted by Tom on March 5, 2000, at 22:11:48
This was sent out yesterday, looks good!
dove
----------------
FDA Approvable Letter Received for Vestra
February 28, 2000
MedscapeWirePharmacia & Upjohn announced today that the US Food and Drug Administration (FDA) has issued a second approvable letter for the company's new antidepressant, Vestra (reboxetine mesylate tablets).
This action requires the company to conduct an additional US clinical study to augment the original New Drug Application (NDA) for VESTRA. The original NDA was accepted for filing by FDA in June 1998, based on studies conducted outside the United States. Pharmacia & Upjohn is in the process of planning this additional US study.
"We are confident about fulfilling the FDA's new request and look forward to bringing this important new class of antidepressants to the US market," said Carrie Cox, executive vice president of Global Business Management.
Vestra is currently marketed by Pharmacia & Upjohn in 18 countries.
Posted by Arne on March 6, 2000, at 9:45:36
In reply to reboxetine, posted by Tom on March 5, 2000, at 22:11:48
>
> ive heard that approval of reboxetine is being held up...by the FDA....could it be that their affraid it might cut into sales profits of american drugs like say prozac.....its all about money...not safteyWell, if you like conspiracy theories, here's one: Eli Lilly, the company behind Prozac, has made a drug called tomoxetine. It is very similar chemically to reboxetine, and it is also a selective noradrenaline reuptake inhibitor. Maybe the FDA is delaying reboxetine so Lilly can get their drug out on the market before P&U.
Posted by Sherry on March 7, 2000, at 13:08:48
In reply to Reboxetine vs tomoxetine, posted by Arne on March 6, 2000, at 9:45:36
Would someone please clarify for me what the difference between desipramine and reboxetine is. I know they both effect levels of NE, and that despram. is a tricyclic, but how do they differ chemically? Also, if someone can not take desipramine is it likely that they could not take reboxetine?
Posted by Cam W. on March 9, 2000, at 10:39:11
In reply to Re: Reboxetine vs tomoxetine, posted by Sherry on March 7, 2000, at 13:08:48
> Would someone please clarify for me what the difference between desipramine and reboxetine is. I know they both effect levels of NE, and that despram. is a tricyclic, but how do they differ chemically? Also, if someone can not take desipramine is it likely that they could not take reboxetine?
Sherry - Reboxetine more selectively blocks norepinephrine reuptake. Desipramine, or more generally TCAs, bind significantly to more receptors (muscarinc/cholinergic, serotonin reuptake, alpha-adrenergic, norepinephrine reuptake, and histaminic receptors). This is why TCAs have so many side effects. Side effects are really only effects of the drug we don't want. A side effect in one disorder may be the mechanism of action in another disorder. Different TCAs have different affinities (or bind stronger) for each of these receptors. For example, Desipramine preferentially binds to (blocks) norepinephrine reuptake receptors and Clomipramine binds stronger to serotonin reuptake receptors. Drug companies develop now develop drugs to bind to as few receptors as possible to minimize side effects. So, you can consider Reboxetine to be like Desipramine, but without as many side effects. Hope this helps - Cam W.
Posted by sherry on March 9, 2000, at 11:09:35
In reply to Re: Reboxetine vs tomoxetine, posted by Cam W. on March 9, 2000, at 10:39:11
> > Would someone please clarify for me what the difference between desipramine and reboxetine is. I know they both effect levels of NE, and that despram. is a tricyclic, but how do they differ chemically? Also, if someone can not take desipramine is it likely that they could not take reboxetine?
>
> Sherry - Reboxetine more selectively blocks norepinephrine reuptake. Desipramine, or more generally TCAs, bind significantly to more receptors (muscarinc/cholinergic, serotonin reuptake, alpha-adrenergic, norepinephrine reuptake, and histaminic receptors). This is why TCAs have so many side effects. Side effects are really only effects of the drug we don't want. A side effect in one disorder may be the mechanism of action in another disorder. Different TCAs have different affinities (or bind stronger) for each of these receptors. For example, Desipramine preferentially binds to (blocks) norepinephrine reuptake receptors and Clomipramine binds stronger to serotonin reuptake receptors. Drug companies develop now develop drugs to bind to as few receptors as possible to minimize side effects. So, you can consider Reboxetine to be like Desipramine, but without as many side effects. Hope this helps - Cam W.Thanks Cam W. for yet another lesson. I am learning a lot from this board, and I always look forward to reading all your posts.~Sherry
Posted by JohnL on March 10, 2000, at 3:57:04
In reply to Re: Reboxetine vs tomoxetine, posted by sherry on March 9, 2000, at 11:09:35
As Cam mentioned, Desipramine affects multiple sites. But I don't think researchers can fully explain the therapeutic mechanisms of the NE antidepresants, because results vary within that class. For example, someone may do poorly on the primarily NE antidepressants Nortriptyline or Protriptyline, and yet do wonderfully on another primarily NE antidepressant Desipramine. They all have major NE reuptake inhibition, but somehow they actually have other subtle poorly understood differences that probably contribute to therapeutic efficacy. I wish it were as easy as NE reuptake or this or that or whatever, but I think it's a whole lot more complex than that.
Posted by Cam W. on March 10, 2000, at 7:35:08
In reply to Re: Reboxetine vs tomoxetine, posted by JohnL on March 10, 2000, at 3:57:04
John is right. It is far more complex than looking at one or two receptors. I have recently read where antidepressants also improve the functioning of neuronal support cells (glia). Another interesting twist in the story. - Cam W.
Posted by Scott L. Schofield on March 10, 2000, at 12:45:34
In reply to Re: Reboxetine vs tomoxetine, posted by Cam W. on March 10, 2000, at 7:35:08
> > > > Would someone please clarify for me what the difference between desipramine and reboxetine is. I know they both effect levels of NE, and that despram. is a tricyclic, but how do they differ chemically? Also, if someone can not take desipramine is it likely that they could not take reboxetine?
> > > Drug companies now develop drugs to bind to as few receptors as possible to minimize side effects. So, you can consider Reboxetine to be like Desipramine, but without as many side effects.> > As Cam mentioned, Desipramine affects multiple sites. But I don't think researchers can fully explain the therapeutic mechanisms of the NE antidepresants, because results vary within that class.
> John is right. It is far more complex than looking at one or two receptors.
I get scared sometimes that drug companies have begun to invest too much into developing drugs that are so specific as to have only one pharmacological action without sufficient grounds to do so. Creating such molecules has great importance in providing tools for elucidating the biology of the human organism in health and disease. However, I'm not sure what criteria are used to decide when to commit the limited resources of a drug company (most importantly, time) into developing such a compound for use as a clinical drug.I really wouldn't mind this sort of thing, were it not to jeopardize my chances of getting well as soon as possible. At the moment, I am all in favor of capitalism. However, I sometimes can't help but to consider the time and money "owned" by a drug company as being part of the collective resources of mankind. I hope the people in a position to make the decisions of how to invest it take this into consideration.
Actually, I'm not sure there is any better way to go about it than the way they do now.
I wonder what ever happened to duloxetine?
- Scott
Posted by Anna P. on March 14, 2000, at 16:32:12
In reply to Reboxetine vs tomoxetine, posted by Arne on March 6, 2000, at 9:45:36
> >
> > ive heard that approval of reboxetine is being held up...by the FDA....could it be that their affraid it might cut into sales profits of american drugs like say prozac.....its all about money...not saftey
>
> Well, if you like conspiracy theories, here's one: Eli Lilly, the company behind Prozac, has made a drug called tomoxetine. It is very similar chemically to reboxetine, and it is also a selective noradrenaline reuptake inhibitor. Maybe the FDA is delaying reboxetine so Lilly can get their drug out on the market before P&U.I agree. I read the article that says people in the US are devoid of good medications because of the existing companies who want to maximize their profit, and this is horrible...
This is the end of the thread.
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