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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 200. This is the beginning of the thread.
Posted by bonnie_ann on January 28, 2002, at 20:01:34
I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
Thanks,
Bonnie
Posted by Cmatt on January 29, 2002, at 5:24:58
In reply to Forest Labs gets US conditional approval for Lexa., posted by bonnie_ann on January 28, 2002, at 20:01:34
It is often in the range of six months or slightly longer before FDA approved drugs reach the market.
Posted by Raga on January 29, 2002, at 7:57:34
In reply to Forest Labs gets US conditional approval for Lexa., posted by bonnie_ann on January 28, 2002, at 20:01:34
Sorry for my ignorance, but what the heck is Lexa?
I did a few google searches, couldn't find anything about a drug named Lexa...Thanks
Posted by Bill L on January 29, 2002, at 8:17:52
In reply to Forest Labs gets US conditional approval for Lexa., posted by bonnie_ann on January 28, 2002, at 20:01:34
I read an update on this yesterday. The new drug's generic name is escitalopram. It's brand name will be Lexapro in the US. FDA approval is expected in the spring 2002. It is an isomer of Celexa (Celexa is also called Cipramil or Citalopram).
Lexapro does have less side effects than Celexa in at least 2 areas: 1) daytime tiredness (somulance) and 2) sexual problems
That's significant because Celexa already has less side effects than other SSRI's for a lot of people.
I have been on Celexa for over 2 years with very good results. I am anxious to switch to Lexapro due to the lower degree of side effects.
In a different article I saw yesterday, a clinical trial showed that Celexa was effective for children and adolesents.
> I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
> And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
> Thanks,
> Bonnie
Posted by djmmm on January 29, 2002, at 20:21:39
In reply to Forest Labs gets US conditional approval for Lexa., posted by bonnie_ann on January 28, 2002, at 20:01:34
> I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
> And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
> Thanks,
> Bonnie"New and Improved" versions of SSRIs leave a bad taste in my mouth...for lack of better words...basically Forest Labs has taken the *active* isomer and isolated it...Im not falling for it, just as Im not falling for the *new* prozac or *sarafem*...
Forest Labs happens to lose its patent rights in the US for Celexa in 2004...I suspect this is the reason for the launch of escitalopram...which sounds like an exotic spanish version of celexa..but it is just the "S" isomer S-Citalopram
Posted by OldSchool on January 30, 2002, at 12:56:43
In reply to Forest Labs gets US conditional approval for Lexa., posted by bonnie_ann on January 28, 2002, at 20:01:34
> I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
> And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
> Thanks,
> BonnieThis is so stupid. Another new SSRI. We already have enough SSRIs on the market, we dont need more. Instead of newer SSRIs how about something new and novel? Like substance P, MAOI patches, etc. This "new and improved" SSRI gets FDA approval? LOL How much do you wanna bet the new selegiline MAOI patch gets shot down by the FDA? A drug that could actually make a difference like the MAOI patch will probably not get passed, but more "me too" SSRIs glide thru easily.
What a crock.
Old School
Posted by SLS on January 31, 2002, at 16:44:49
In reply to Re: Forest Labs gets US conditional approval for Lexa., posted by OldSchool on January 30, 2002, at 12:56:43
> > I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
> > And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
> > Thanks,
> > Bonnie
>
> This is so stupid. Another new SSRI. We already have enough SSRIs on the market, we dont need more. Instead of newer SSRIs how about something new and novel? Like substance P, MAOI patches, etc. This "new and improved" SSRI gets FDA approval? LOL How much do you wanna bet the new selegiline MAOI patch gets shot down by the FDA? A drug that could actually make a difference like the MAOI patch will probably not get passed, but more "me too" SSRIs glide thru easily.
>
> What a crock.
>
> Old School
Hi Old School.For every new antidepressant that becomes available, a grateful percentage of previously untreatable people are awakened from their nightmare of misery. That some people respond to Celexa who had not responded to Paxil should justify the availability of Celexa. I'm not sure that the approval of "me too" drugs impedes in any way the development of novel drugs. On the contrary, I worry that a stampede towards novel drugs might hinder the development of superior "me too" drugs. Personally, I would gladly trade Prozac and Paxil for a single new drug of a novel class. I responded to neither of them.
Just an opinion from a yet untreatable person.
- Scott
Posted by OldSchool on January 31, 2002, at 16:49:29
In reply to Re: Forest Labs gets US conditional approval for Lexa., posted by SLS on January 31, 2002, at 16:44:49
> > > I read that it will be marketed by mid year pending FDA clearance. Does anyone know about how long does it take for my DR to able to prescribe it?
> > > And is it supposed to have a better side effect profile than Celexa? Primarily sexual dysfunction?
> > > Thanks,
> > > Bonnie
> >
> > This is so stupid. Another new SSRI. We already have enough SSRIs on the market, we dont need more. Instead of newer SSRIs how about something new and novel? Like substance P, MAOI patches, etc. This "new and improved" SSRI gets FDA approval? LOL How much do you wanna bet the new selegiline MAOI patch gets shot down by the FDA? A drug that could actually make a difference like the MAOI patch will probably not get passed, but more "me too" SSRIs glide thru easily.
> >
> > What a crock.
> >
> > Old School
>
>
> Hi Old School.
>
> For every new antidepressant that becomes available, a grateful percentage of previously untreatable people are awakened from their nightmare of misery. That some people respond to Celexa who had not responded to Paxil should justify the availability of Celexa. I'm not sure that the approval of "me too" drugs impedes in any way the development of novel drugs. On the contrary, I worry that a stampede towards novel drugs might hinder the development of superior "me too" drugs. Personally, I would gladly trade Prozac and Paxil for a single new drug of a novel class. I responded to neither of them.
>
> Just an opinion from a yet untreatable person.
>
>
>
>
> - ScottScott, I seriously doubt any real treatment resistant people are going to be helped by a "new and improved" Celexa. Get real. Its a waste of time. Celexa is already good enough. Develop another kind of drug and move on.
Old School
Posted by IsoM on January 31, 2002, at 17:04:53
In reply to Re: Forest Labs gets US conditional approval for Lexa., posted by OldSchool on January 31, 2002, at 16:49:29
The development of the new Celexa is meant to be an improvement in its effectiveness - it's meant to have fewer side-effects. Most of the side-effects experienced comes from the ineffective isomer of Celexa. Take that away & you'll still get the same response as you did to the old Celexa but without as many troubling side-effects.
There are teams of earnest young scientists working together to come up with new ADs but drugs can only be chemically engineered & carefully tailored for each specific need as more is learned about how our body's many functions interact. That's why one class is called "Selective" serotonin reuptake inhibitors. There's many sites throughout the body where serotonin has its effects, these try to target slective sites. If drugs could be even more tailored to just fit the ones that need to be targeted - result is more effective meds with fewer side-effects.
Drug engineering is really only in its infancy. We're only at the "leeches & blood-letting" stage, so to speak, but at this point in time, it's the best we've got. Would it be more cruel to hold back simply because we haven't progressed enough? Or to provide treatment such as we have now?
(Not to say I don't think pharmaceutical firms don't push their products forcefully on the market - but that's another story.)
Posted by Geezer on January 31, 2002, at 18:57:39
In reply to Re: Forest Labs gets US conditional approval for Lexa., posted by SLS on January 31, 2002, at 16:44:49
I have to vote with Old School on this one. SSRI,s are fine but some of us are over due for something that works. The MAOI patch would be a real blessing but, then again, I can't get an MAOI anyhow because the trial lawyers have the pdocs running scarred. Let's not overlook the real PROBLEM.....the FDA. Thirty years in the medical device industry (cardiac pacemakers) made one thing perfectly clear - if the FDA would confine itself to the safe labeling of cans of corn in the super market, we would all be better off. It is easy to defile the drug companies on the basis of profit, however, they do the significant LONG TERM testing in Europe-the FDA ignores that, requires retesting here, delays and or denies release. Keep the jelly beans....its time for real meds.
Posted by OldSchool on January 31, 2002, at 19:19:29
In reply to Reason For Release of New Drugs, posted by IsoM on January 31, 2002, at 17:04:53
> The development of the new Celexa is meant to be an improvement in its effectiveness - it's meant to have fewer side-effects. Most of the side-effects experienced comes from the ineffective isomer of Celexa. Take that away & you'll still get the same response as you did to the old Celexa but without as many troubling side-effects.
>
> There are teams of earnest young scientists working together to come up with new ADs but drugs can only be chemically engineered & carefully tailored for each specific need as more is learned about how our body's many functions interact. That's why one class is called "Selective" serotonin reuptake inhibitors. There's many sites throughout the body where serotonin has its effects, these try to target slective sites. If drugs could be even more tailored to just fit the ones that need to be targeted - result is more effective meds with fewer side-effects.
>
> Drug engineering is really only in its infancy. We're only at the "leeches & blood-letting" stage, so to speak, but at this point in time, it's the best we've got. Would it be more cruel to hold back simply because we haven't progressed enough? Or to provide treatment such as we have now?
>
> (Not to say I don't think pharmaceutical firms don't push their products forcefully on the market - but that's another story.)A "new and improved" Celexa is silly. Celexa already has a reputation as being one of the antidepressants with the fewest side effects. In fact thats one of the reasons Celexa was originally marketed. Its marketed as the "SSRI with the favorable side effect profile." We dont need a new and improved Celexa.
The amount of money spent on developing this new and improved Celexa could have been spent on something else...something better than a new SSRI. The real reason this new and improved Celexa is being developed is one reason. Money. $$$$$$ Its so the company that sells Celexa can continue to make a big profit on it. Thats all. Seems like someone on here mentioned that the current Celexa patent is about to run out. Thus the financial incentive to develop this "new and improved" Celexa. Give me a break.
SSRIs are big money and drug companies love them because these drugs are very safe. Nobody seems to want to develop better drugs or drugs oriented for treatment resistant depressives. Just plug along doing the same old crap. SSRIs and serotonin drugs. Yawn. SSRIs do not work for 20% to 30% of those who take them.
I also do not believe this new Celexa will be more effective than the original Celexa. It probably has a better side effect profile, but more effective? I SERIOUSLY doubt it!
I have one word to describe this "new and improved" Celexa. Bullshit.
Old School
Posted by Mr. Scott on January 31, 2002, at 21:31:39
In reply to Re: Reason For Release of New Drugs, posted by OldSchool on January 31, 2002, at 19:19:29
> > The development of the new Celexa is meant to be an improvement in its effectiveness - it's meant to have fewer side-effects. Most of the side-effects experienced comes from the ineffective isomer of Celexa. Take that away & you'll still get the same response as you did to the old Celexa but without as many troubling side-effects.
> >
> > There are teams of earnest young scientists working together to come up with new ADs but drugs can only be chemically engineered & carefully tailored for each specific need as more is learned about how our body's many functions interact. That's why one class is called "Selective" serotonin reuptake inhibitors. There's many sites throughout the body where serotonin has its effects, these try to target slective sites. If drugs could be even more tailored to just fit the ones that need to be targeted - result is more effective meds with fewer side-effects.
> >
> > Drug engineering is really only in its infancy. We're only at the "leeches & blood-letting" stage, so to speak, but at this point in time, it's the best we've got. Would it be more cruel to hold back simply because we haven't progressed enough? Or to provide treatment such as we have now?
> >
> > (Not to say I don't think pharmaceutical firms don't push their products forcefully on the market - but that's another story.)
>
> A "new and improved" Celexa is silly. Celexa already has a reputation as being one of the antidepressants with the fewest side effects. In fact thats one of the reasons Celexa was originally marketed. Its marketed as the "SSRI with the favorable side effect profile." We dont need a new and improved Celexa.
>
> The amount of money spent on developing this new and improved Celexa could have been spent on something else...something better than a new SSRI. The real reason this new and improved Celexa is being developed is one reason. Money. $$$$$$ Its so the company that sells Celexa can continue to make a big profit on it. Thats all. Seems like someone on here mentioned that the current Celexa patent is about to run out. Thus the financial incentive to develop this "new and improved" Celexa. Give me a break.
>
> SSRIs are big money and drug companies love them because these drugs are very safe. Nobody seems to want to develop better drugs or drugs oriented for treatment resistant depressives. Just plug along doing the same old crap. SSRIs and serotonin drugs. Yawn. SSRIs do not work for 20% to 30% of those who take them.
>
> I also do not believe this new Celexa will be more effective than the original Celexa. It probably has a better side effect profile, but more effective? I SERIOUSLY doubt it!
>
> I have one word to describe this "new and improved" Celexa. Bullshit.
>
> Old SchoolI couldn't agree more... Remember "The Purple Pill" called Prilosec for GERD. They tweaked the molecule just in time for the patent to expire and create "The New Purple Pill" Nexium.
Posted by Mr. Scott on January 31, 2002, at 21:33:51
In reply to Re: Reason For Release of New Drugs, posted by OldSchool on January 31, 2002, at 19:19:29
New chemicals in phase III from Pfizer.
Anticonvulsant, GAD, Panic, Bipolar indications.
Maybe something new on the tolerability front anyways..
Scott
Posted by 3 Beer Effect on January 31, 2002, at 21:33:59
In reply to Re: Reason For Release of New Drugs, posted by OldSchool on January 31, 2002, at 19:19:29
Posted by Ritch on February 1, 2002, at 0:53:36
In reply to Pagoclone and Pregabalin , posted by Mr. Scott on January 31, 2002, at 21:33:51
> New chemicals in phase III from Pfizer.
>
> Anticonvulsant, GAD, Panic, Bipolar indications.
>
> Maybe something new on the tolerability front anyways..
>
> Scott
I am very curious about pregabalin. I already plan to switch from gabapentin to pregabalin when it becomes available. I plan to switch from citalopram to escitalopram when it is available and I would like to try a *tiny* dose of Focalin in combination with them. I just have a very strong hunch it might work quite well...Mitch
Posted by IsoM on February 1, 2002, at 1:23:14
In reply to Re: Reason For Release of New Drugs, posted by OldSchool on January 31, 2002, at 19:19:29
Old School, we're both on the same side, even if our comments seem not to be. I thoroughly do agree with you about putting money into developing truly new drugs & that they're already tested long enough in Europe without the FDA needing to spend years more.
The point I was trying to make was that the new Celexa ISN'T more effective than the old. Just that side-effects that bother a few will be much less. I'd also like to explain a little about chemistry, if you wouldn't mind.
Compounds that consist of two different isomers are called racemic mixtures. One of the isomers is effective & the other often isn't. But it still can have an effect on the body. Thalidomide that was prescribed for morning sickness in pregnant women a few decades ago was a racemic compound. The birth defects that were caused by thalidomide (seal flipper-like limbs) was a result of the ineffective isomer of thalidomide.
Research has come a long ways & has now developed a relatively simple method to separate a racemic mixture. This has being done with thalidomide & it's now used in treating leprosy. Millions of dollars were not poured into developing a new Celexa - instead new developments are being applied to different areas & one of them is in the separation of the two isomers of Celexa. Plain & simple.
And yes, I do believe that the original patent running out on Celexa has a lot to do with the timing of the release of the new compound. I just like to separate the truth from the accusations. If information isn't accurate & has too much rhetoric to it, fewer people will be convinced.
Posted by IsoM on February 1, 2002, at 1:26:34
In reply to Re: Reason For Release of New Drugs » OldSchool, posted by Mr. Scott on January 31, 2002, at 21:31:39
Posted by OldSchool on February 1, 2002, at 10:08:16
In reply to Re: Reason For Release of New Drugs » OldSchool, posted by Mr. Scott on January 31, 2002, at 21:31:39
> I couldn't agree more... Remember "The Purple Pill" called Prilosec for GERD. They tweaked the molecule just in time for the patent to expire and create "The New Purple Pill" Nexium.
I havent read or heard that before, but it sounds logical. It doesnt surprise me at all. Pure bullshit is what it is.
Posted by OldSchool on February 1, 2002, at 10:12:36
In reply to Re: about the new Celexa » OldSchool, posted by IsoM on February 1, 2002, at 1:23:14
> Old School, we're both on the same side, even if our comments seem not to be. I thoroughly do agree with you about putting money into developing truly new drugs & that they're already tested long enough in Europe without the FDA needing to spend years more.
>
> The point I was trying to make was that the new Celexa ISN'T more effective than the old. Just that side-effects that bother a few will be much less. I'd also like to explain a little about chemistry, if you wouldn't mind.
>
> Compounds that consist of two different isomers are called racemic mixtures. One of the isomers is effective & the other often isn't. But it still can have an effect on the body. Thalidomide that was prescribed for morning sickness in pregnant women a few decades ago was a racemic compound. The birth defects that were caused by thalidomide (seal flipper-like limbs) was a result of the ineffective isomer of thalidomide.
>
> Research has come a long ways & has now developed a relatively simple method to separate a racemic mixture. This has being done with thalidomide & it's now used in treating leprosy. Millions of dollars were not poured into developing a new Celexa - instead new developments are being applied to different areas & one of them is in the separation of the two isomers of Celexa. Plain & simple.
>
> And yes, I do believe that the original patent running out on Celexa has a lot to do with the timing of the release of the new compound. I just like to separate the truth from the accusations. If information isn't accurate & has too much rhetoric to it, fewer people will be convinced.Whatever. All I have to say about this "new and improved" Celexa is the company that makes it can shove their new Celexa.
Obviously you respond well to plain old SSRIs. I dont. And neither do 20% to 30% of my depressive brothers. What is being done about them? Not much, IMO.
Old School
Posted by Ritch on February 1, 2002, at 12:25:07
In reply to Re: about the new Celexa, posted by OldSchool on February 1, 2002, at 10:12:36
> Obviously you respond well to plain old SSRIs. I dont. And neither do 20% to 30% of my depressive brothers. What is being done about them? Not much, IMO.
>
> Old SchoolHi, I doubt if escitalopram is going to improve my positive response to citalopram, but I get bad heartburn and GI distress from SSRI's (which is dose related). If I can take *half* as much escitalopram to get the same positive effects I get now with much less heartburn I will spend the money.
Mitch
Posted by bonnie_ann on February 1, 2002, at 17:29:16
In reply to Re: about the new Celexa » OldSchool, posted by Ritch on February 1, 2002, at 12:25:07
I will be first in line when this is available.
It would be great if I could just take the Lexapro at 10mg and not have to worry about tiredness and sexual dysfunction and all the other side effects.
Cause now I have to take Wellbutrin and less Celexa than I should, to stay awake and have a sexlife.
It's not the same as
Sarafem = Prozac
Zyban = Wellbutrin
It's a whole different approach and in my book this IS progress.
Bonnie
Posted by Dr. Bob on February 1, 2002, at 20:04:19
In reply to Re: Reason For Release of New Drugs, posted by OldSchool on February 1, 2002, at 10:08:16
> Pure bullshit is what it is.
It's fine to express strong opinions, but please don't use language that might offend others, thanks.
Bob
PS: Follow-ups regarding civility should be redirected to Psycho-Babble Administration.
Posted by mr.scott on February 1, 2002, at 21:28:01
In reply to Re: Forest Labs gets US conditional approval for Lexa., posted by SLS on January 31, 2002, at 16:44:49
Posted by Ritch on February 1, 2002, at 22:48:21
In reply to Will try it, but not impressed! (nm), posted by mr.scott on February 1, 2002, at 21:28:01
I have always wondered about the "mechanism" of SSRI's being responsible for their antidepressant effects AND the side effects you get from sertonin reuptake inhibition versus the medicine itself that "happens" to be an SSRI.
In other words, if the "R" isomer of citalopram is a therapeutic dud (depression, etc.-wise) and the "S" isomer is responsible for the therapeutic effects. Could it also mean that the dud isomer causes *less* side effects than the active one because it doesn't do much to block 5-HT reuptake? In that case, there shouldn't be much therapeutic or side-effect advantage to taking escitalopram. The only advantage would be less medication for your liver to get rid of. I will try it and see as well and post the results.
Mitch
Posted by ben on February 2, 2002, at 10:10:56
In reply to Re: Will try it, but not impressed! » mr.scott, posted by Ritch on February 1, 2002, at 22:48:21
No. r-citalopram is supposed to responsible for the side-effects, at least for more side effects than s-citalopram. Thats why they leave the r-isomere away. Lilly is planning this with Prozac (fluoxetine) too.
> I have always wondered about the "mechanism" of SSRI's being responsible for their antidepressant effects AND the side effects you get from sertonin reuptake inhibition versus the medicine itself that "happens" to be an SSRI.
>
> In other words, if the "R" isomer of citalopram is a therapeutic dud (depression, etc.-wise) and the "S" isomer is responsible for the therapeutic effects. Could it also mean that the dud isomer causes *less* side effects than the active one because it doesn't do much to block 5-HT reuptake? In that case, there shouldn't be much therapeutic or side-effect advantage to taking escitalopram. The only advantage would be less medication for your liver to get rid of. I will try it and see as well and post the results.
>
> Mitch
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