![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 17 of 17. This is the beginning of the thread.
Posted by jrbecker on September 16, 2005, at 15:31:54
http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/102505_chronicA.htm
Psychopharmacologic Drugs Advisory Committee To Review Need For Longer-Term Efficacy Data
FDA’s Psychopharmacologic Drugs Advisory Committee will meet Oct. 25 to discuss the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders and optimal study designs for obtaining valid information about longer-term benefits of drug treatment.On Oct. 26 the committee will discuss whether or not dietary restrictions should be imposed on Somerset’s depression therapy Emsam (selegiline).
To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email webcasthelp@elsevier.com or call 800-627-8171.
Posted: Friday, September 16, 2005
Posted by linkadge on September 16, 2005, at 16:55:47
In reply to FDA panel to review EMSAM on Oct 25th, posted by jrbecker on September 16, 2005, at 15:31:54
How well did this med do in terms of superiority over placebo in depression ?
Linkadge
Posted by EERRIICC on September 16, 2005, at 20:02:02
In reply to FDA panel to review EMSAM on Oct 25th, posted by jrbecker on September 16, 2005, at 15:31:54
Thanks jrbecker for always posting the most important new developments in the world of mental health. It is much appreciated.
Eric
Posted by SFY on September 20, 2005, at 21:46:49
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by linkadge on September 16, 2005, at 16:55:47
> How well did this med do in terms of superiority over placebo in depression ?
>
>
>
> LinkadgeFor a 20 mg. dosage, it had a small but statistically significant benefit over placebo.
Posted by SFY on September 20, 2005, at 21:48:56
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by linkadge on September 16, 2005, at 16:55:47
The full text of a study with similar results:
http://ajp.psychiatryonline.org/cgi/content/full/159/11/1869
Posted by Cecilia on September 21, 2005, at 3:43:04
In reply to Re: FDA panel to review EMSAM on Oct 25th » linkadge, posted by SFY on September 20, 2005, at 21:48:56
I`m curious and a little suspicious about the lack of side effects reported with these studies. You`re bypassing the GI tract, so you shouldn`t have gastrointestinal side effects, but the drug is still going into your blood stream so I`m not clear why all the other bad MAO side effects are reportedly absent. If this ever gets approved it`ll be interesting to see what happens in real life. Cecilia
Posted by SFY on September 21, 2005, at 12:50:27
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by Cecilia on September 21, 2005, at 3:43:04
The food interaction issue is the hangup on approval. The studies show no food interaction issues and the company wants to market Emsam without the dietary restrictions. Otherwise, there is very little advantage over Nardil and Parnate. The FDA asked for more data on this issue which has been the primary reason for the hold up in final approval.
Posted by cecilia on September 21, 2005, at 18:35:58
In reply to Re: FDA panel to review EMSAM on Oct 25th » Cecilia, posted by SFY on September 21, 2005, at 12:50:27
> The food interaction issue is the hangup on approval. The studies show no food interaction issues and the company wants to market Emsam without the dietary restrictions. Otherwise, there is very little advantage over Nardil and Parnate. The FDA asked for more data on this issue which has been the primary reason for the hold up in final approval.
Beyond the food issues, it seems to me that Emsam would have enormous advantages over Nardil and Parnate (neither of which I could tolerate) in terms of side effects. IF what was written about lack of side effects with Emsam is true, but like I said, I'm very very suspicious. Cecilia
Posted by gromit on September 22, 2005, at 10:48:46
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by cecilia on September 21, 2005, at 18:35:58
> Beyond the food issues, it seems to me that Emsam would have enormous advantages over Nardil and Parnate (neither of which I could tolerate) in terms of side effects. IF what was written about lack of side effects with Emsam is true, but like I said, I'm very very suspicious. Cecilia
Doesn't selegeline have a better side effect profile anyway, patch form or not?
Posted by SFY on September 22, 2005, at 13:45:12
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by gromit on September 22, 2005, at 10:48:46
> > Beyond the food issues, it seems to me that Emsam would have enormous advantages over Nardil and Parnate (neither of which I could tolerate) in terms of side effects. IF what was written about lack of side effects with Emsam is true, but like I said, I'm very very suspicious. Cecilia
>
> Doesn't selegeline have a better side effect profile anyway, patch form or not?Most people take selegiline at low doses which don't require dietary restrictions and which minimize the side effects. There's very limited information on the use of high doses of selegiline.
If selegiline had a better side effect profile than Nardil or Parnate then, absent the lack of dietary restrictions, what would be the benefit of Emsam over oral selegiline? (Esp. since you can get selegiline as a relatively cheap generic.)
Posted by Ktemene on September 22, 2005, at 15:14:54
In reply to Re: FDA panel to review EMSAM on Oct 25th » gromit, posted by SFY on September 22, 2005, at 13:45:12
The person who discovered selegiline, Joseph Kroll, does think that it is less likely to cause the cheese reaction than other MAOI's. (I have been told that Kroll thinks that through some mechanism selegiline at least to some degree acts to prevent tyramine from replacing norepinephrine in brain neurons, and it is because these neurons tend to soak up tyramine that they expel norepinephrine to make room for more tyramine, and it is the excess intercellular norepinephrine that causes the acute rise in blood pressure.) (Knoll, J. (1983) Deprenyl (selegeline):the history of its development and pharmacological action Acta Neurol Scand (Suppl)95, 57-80.) But selegiline still does cause this high blood pressure reaction in some cases, and that is why the diet restrictions apply for people taking more than 10mg per day. But in some other respects selegiline does not have a better side effect profile than other MAOI's. I haven't seen reports on clinical trials showing this, but I suspect that selegiline causes more insomnia than Nardil does.
If the FDA allows the transdermal patch to be sold without diet restrictions, this will be an advantage that transdermal selegiline will have in comparison to other MAOI's. But the transdermal delivery system has one other advantage. It avoids the first pass effect which is apparently very great in the case of selegiline. Because the transdermal delivery system means selegiline gets into the bloodstream before it is metabolized in the liver, a much higher percentage of selegiline is active in the body. And this seems to make a big difference, at least for some people. At any rate, several people who were part of the clinical trials of the selegiline transdermal patch reported on Babble much greater antidepressant effects from the patch than from higher doses of the oral form of selegiline. The person who wrote best about his experience with the patch is Adam, who got well and doesn’t drop by very often, so I have copied the URL’s of some of his posts below.
Adam on the patch vs. oral selegiline:
http://www.dr-bob.org/babble/20001115/msgs/49187.htmlAdam’s initial reaction to the patch:
http://www.dr-bob.org/babble/19991001/msgs/12534.htmlAdam’s thoughts on the patch a year later:
http://www.dr-bob.org/babble/20001115/msgs/48935.html
Posted by ravenstorm on September 24, 2005, at 9:37:17
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by Ktemene on September 22, 2005, at 15:14:54
The patch probably isn't going to be good for agitated depression though, will it? I think selegine is activating
Posted by Cecilia on September 25, 2005, at 5:01:07
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by ravenstorm on September 24, 2005, at 9:37:17
> The patch probably isn't going to be good for agitated depression though, will it? I think selegine is activating
Ravenstorm, I wonder about this too. I just don`t believe the abstracts about lack of side effects, I don`t see how it can NOT cause increased anxiety/insomnia. Though frankly I doubt it will be appoved, the FDA has had so much bad publicity with Vioxx etc that they`re probably not going to approve it without dietary restrictions, and I`ve heard the company will probably drop it in that case. I`m afraid to get my hopes up, I guess. Cecilia
Posted by Ktemene on September 25, 2005, at 13:10:44
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by ravenstorm on September 24, 2005, at 9:37:17
> The patch probably isn't going to be good for agitated depression though, will it? I think selegine is activating
My guess is that you're right about that. Selegiline will probably help a higher percentage of people who have atypical depression, the sort of people who are more likely to be helped by Parnate. But, everybody is different, and, as Dr. Bob says, YMMV. I always assumed that selegiline would be bad for people who suffered from anxiety. But pseudonym has had great success treating anxiety disorders with selegiline. So much so that pseudonym rarely posts anymore. I copied (w/ URL) one of the last posts on selegline I remember from pseudonym below.
URL: http://www.dr-bob.org/babble/20041211/msgs/430276.htmlSelegiline working well
Posted by pseudonym on December 16, 2004, at 11:50:19
Hello,I am pleased to report that selegiline (5mg bid) is working well. I take it in combination with 800mg of phenylalanine in the morning, and by itself in the midafternoon. I have been given SSRI's, but they just didn't do the trick for my diagnosis (generalized + social anixety). I can tell you this though, I've been doing so well, that I don't bother reading Psycho-Babble. So, in my case, there is truth to the notion that if you're feeling well, there not much motivation to read or post.
Posted by ravenstorm on September 25, 2005, at 13:25:37
In reply to Re: FDA panel to review EMSAM on Oct 25th » ravenstorm, posted by Ktemene on September 25, 2005, at 13:10:44
Actually, that post for me just confirms that it WON'T be good for people with physical anxiety. He/she was also taking phenylaline--which horribly exacerbates my anxiety. Sounds like they had a mild case of social anxiety, which is totally different from bone shaking physical anxiety!
Posted by gibber on September 25, 2005, at 17:32:44
In reply to FDA panel to review EMSAM on Oct 25th, posted by jrbecker on September 16, 2005, at 15:31:54
If the FDA approves EMSAM without diet restrictions on the 26th how long until it's on the market?
Gibber
Posted by michael on October 18, 2005, at 15:22:52
In reply to FDA panel to review EMSAM on Oct 25th, posted by jrbecker on September 16, 2005, at 15:31:54
Does anyone know what this Oct. 25 meeting means / implies with respect to when the patch might actually reach the market? [and US?]
... the last I heard was someone here estimating that some time around Thanksgiving, Emsam would finally be "available". Does this meeting imply a delay to that time line?
Anybody familiar enough with the workings of the FDA to explain/guess where the patch ultimately IS - with respect to "the end" of this process?
Thanks for any feedback / insights.
michael
>
> http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/102505_chronicA.htm
>
>
> Psychopharmacologic Drugs Advisory Committee To Review Need For Longer-Term Efficacy Data
>
>
> FDA’s Psychopharmacologic Drugs Advisory Committee will meet Oct. 25 to discuss the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders and optimal study designs for obtaining valid information about longer-term benefits of drug treatment.
>
> On Oct. 26 the committee will discuss whether or not dietary restrictions should be imposed on Somerset’s depression therapy Emsam (selegiline).
>
> To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email webcasthelp@elsevier.com or call 800-627-8171.
>
> Posted: Friday, September 16, 2005
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.