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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 25 of 25. This is the beginning of the thread.
Posted by jrbecker on June 16, 2005, at 9:28:26
http://biz.yahoo.com/prnews/050616/lath022.html?.v=13
Posted by iforgotmypassword on June 16, 2005, at 9:44:09
In reply to EMSAM(R) Approval timeline set, posted by jrbecker on June 16, 2005, at 9:28:26
is this actually progress or just more red tape?
Posted by jrbecker on June 16, 2005, at 10:06:17
In reply to uhhhhhhh..., posted by iforgotmypassword on June 16, 2005, at 9:44:09
> is this actually progress or just more red tape?
bottomline, the PDUFA goal date means that the FDA has to make its decision regarding approval by Nov 27th. So, yes, in a way this is progress since the drug has been in limbo with the FDA for over 3 years now.
Posted by Ktemene on June 16, 2005, at 12:38:52
In reply to EMSAM(R) Approval timeline set, posted by jrbecker on June 16, 2005, at 9:28:26
It has been five and a half years since Adam posted about the remarkable recovery he achieved when the Selegiline patch was in clinical trials.
http://www.dr-bob.org/babble/19991001/msgs/12534.html
Adam's doctors thought then that the patch would be available in less than two years!
Posted by KaraS on June 16, 2005, at 17:01:52
In reply to Re: uhhhhhhh... » iforgotmypassword, posted by jrbecker on June 16, 2005, at 10:06:17
> > is this actually progress or just more red tape?
>
> bottomline, the PDUFA goal date means that the FDA has to make its decision regarding approval by Nov 27th. So, yes, in a way this is progress since the drug has been in limbo with the FDA for over 3 years now.
I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
Posted by SFY on June 17, 2005, at 14:25:30
In reply to Re: uhhhhhhh... » jrbecker, posted by KaraS on June 16, 2005, at 17:01:52
> I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
I think it's an issue of whether the FDA approves marketing it without the usual MAOI dietary restrictions attached.
Posted by KaraS on June 17, 2005, at 16:15:30
In reply to Re: uhhhhhhh... » KaraS, posted by SFY on June 17, 2005, at 14:25:30
> > I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
>
> I think it's an issue of whether the FDA approves marketing it without the usual MAOI dietary restrictions attached.
>
>That makes sense. Thanks.
Posted by gromit on June 17, 2005, at 18:25:52
In reply to Re: uhhhhhhh... » SFY, posted by KaraS on June 17, 2005, at 16:15:30
> > > I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
> >
> > I think it's an issue of whether the FDA approves marketing it without the usual MAOI dietary restrictions attached.
> >
> >
>
> That makes sense. Thanks.I don't know if this is the appropriate forum or if anyone will notice this post. I've been wanting to try ensam for a while now, recently I became allergic to the testosterone patches I've been using. I get a raised red area the exact size and shape of the reservoir part. The band aid part doesn't cause any problems, if I remove some of the gel and rub it on that doesn't cause a reaction either. I'm wondering if it's something in the gel that evaporates when out of the patch, the membrane material maybe?
Anyone have any ideas why this would be happening? I'm hoping this thing doesn't finally come out and it turns out I can't tolerate it.
Rick
Posted by KaraS on June 17, 2005, at 19:03:33
In reply to Re: Allergic to patch?, posted by gromit on June 17, 2005, at 18:25:52
> > > > I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
> > >
> > > I think it's an issue of whether the FDA approves marketing it without the usual MAOI dietary restrictions attached.
> > >
> > >
> >
> > That makes sense. Thanks.
>
> I don't know if this is the appropriate forum or if anyone will notice this post. I've been wanting to try ensam for a while now, recently I became allergic to the testosterone patches I've been using. I get a raised red area the exact size and shape of the reservoir part. The band aid part doesn't cause any problems, if I remove some of the gel and rub it on that doesn't cause a reaction either. I'm wondering if it's something in the gel that evaporates when out of the patch, the membrane material maybe?
>
> Anyone have any ideas why this would be happening? I'm hoping this thing doesn't finally come out and it turns out I can't tolerate it.
>
>
> Rick
I've been worried about the same thing since even band-aids can cause allergic reactions for me. I wish I could find out if anyone here has had a patch for any reason that they couldn't tolerate initially but them they were given something that allowed them to tolerate the patch. I believe I posted something to this effect a while ago on the health board but I didn't get that kind of a response.I wonder if it's possible to contact the company that makes emsam and ask about this.
K
Posted by ed_uk on June 17, 2005, at 19:29:29
In reply to Re: Allergic to patch? » gromit, posted by KaraS on June 17, 2005, at 19:03:33
Hi K!
>I've been worried about the same thing since even band-aids can cause allergic reactions for me.
Perhaps you could try sublingual selegiline instead. It's available in the UK. Do you think you could get hold of some if necessary?
Ed xx
Posted by TomG on June 17, 2005, at 20:42:45
In reply to Re: Allergic to patch? » KaraS, posted by ed_uk on June 17, 2005, at 19:29:29
try this patch in combo with an AP. Keep tabs with me. I'm anxiously awaiting it's arrival. Good news. Good news.
Tom
Posted by Jakeman on June 17, 2005, at 20:56:32
In reply to EMSAM(R) Approval timeline set, posted by jrbecker on June 16, 2005, at 9:28:26
Several people on this board have reported adverse side effects from oral segiline, such as anxiety and insomnia. Does the patch improve on this kind of side effects?
warm regards, ~ Jake
> http://biz.yahoo.com/prnews/050616/lath022.html?.v=13
>
>
Posted by Declan on June 17, 2005, at 22:45:56
In reply to Re: Allergic to patch?, posted by gromit on June 17, 2005, at 18:25:52
Hi Rick
Testosterone patches are well known for producing irritation, especially in hot weather. In Australia my dr says they are no good north of Sydney. I guess it's summer where you are.I don't understand the MAOI/patch/absorption through the small intestine thing. You know the post about making Nardil much more effective (by Michael Bell I think.) The idea was Nardil should be absorbed through the small intestine because that's where most MAO A is. And then someone else was talking about Parnate perhaps, dissolved in the mouth. And then the idea of a Nardil and Parnate patch to overcome the dietary thing. I've always taken deprenyl under the tongue.
Anyone got any ideas??
Posted by KaraS on June 17, 2005, at 22:48:12
In reply to Re: Allergic to patch? » KaraS, posted by ed_uk on June 17, 2005, at 19:29:29
> Hi K!
>
> >I've been worried about the same thing since even band-aids can cause allergic reactions for me.
>
> Perhaps you could try sublingual selegiline instead. It's available in the UK. Do you think you could get hold of some if necessary?
>
> Ed xx
Hi Ed,I wouldn't start it now because i have to stay clean for the rEEG scan but it may be something to consider down the road.
Would the sublingual selegiline also obviate the need for the MAOI diet? If so, then why do we need to wait for the patch at all? Maybe it's a lot harder to get doctors to prescribe the sublingual selegiline where as if the patch were released and promoted here, then mainstream doctors would be willing to prescribe it.
K
xxx
Posted by Declan on June 17, 2005, at 22:50:30
In reply to Re: EMSAM(R) Approval timeline set, posted by Jakeman on June 17, 2005, at 20:56:32
I'd have anxiety and *insomnia* big time if I took some of the doses I've read about, especially if with DLPA or tyrosine. Today I took 2mg which I can feel, what with some free form amino acids in my protein shake.
Declan
Posted by gromit on June 17, 2005, at 23:26:40
In reply to Re: Allergic to patch?, posted by Declan on June 17, 2005, at 22:45:56
Hi
> Testosterone patches are well known for producing irritation, especially in hot weather. In Australia my dr says they are no good north of Sydney. I guess it's summer where you are.
Yes I think it's summer here, it's been warm anyway, I can't keep track of these things for some reason. Thanks for posting that, I feel better about my chances now.
Rick
Posted by gromit on June 17, 2005, at 23:49:25
In reply to Re: Allergic to patch? » ed_uk, posted by KaraS on June 17, 2005, at 22:48:12
> Would the sublingual selegiline also obviate the need for the MAOI diet? If so, then why do we need to wait for the patch at all? Maybe it's a lot harder to get doctors to prescribe the sublingual selegiline where as if the patch were released and promoted here, then mainstream doctors would be willing to prescribe it.
I've wondered the same thing about sublingual selegiline, I know I've read that SHOULD be the case. I don't think there is a sublingual form available in the US. I imported some liquid, can't remember the measurement they use but I think it amounted to 300 mg, for about $90. Depending on your dose that could be pretty reasonable. At 10 mg a day it isn't, at least for me.
I've searched for, but never found again a post where someone claimed a really low dose, like 1-2 mg a day, would eventually give almost complete inhibition.
Rick
Posted by KaraS on June 18, 2005, at 2:33:19
In reply to Re: Allergic to patch? » KaraS, posted by gromit on June 17, 2005, at 23:49:25
> > Would the sublingual selegiline also obviate the need for the MAOI diet? If so, then why do we need to wait for the patch at all? Maybe it's a lot harder to get doctors to prescribe the sublingual selegiline where as if the patch were released and promoted here, then mainstream doctors would be willing to prescribe it.
>
> I've wondered the same thing about sublingual selegiline, I know I've read that SHOULD be the case. I don't think there is a sublingual form available in the US. I imported some liquid, can't remember the measurement they use but I think it amounted to 300 mg, for about $90. Depending on your dose that could be pretty reasonable. At 10 mg a day it isn't, at least for me.
>
> I've searched for, but never found again a post where someone claimed a really low dose, like 1-2 mg a day, would eventually give almost complete inhibition.
>
>
> Rick
>Actually it may be a moot point. I found the following on PubMed. It's not encouraging.
Sublingual selegiline: new formulation. New formulation: new risk of oral adverse effects.
[No authors listed]
There is no evidence that sublingual selegiline reduces the risk of adverse effects associated with oral selegiline. On the contrary, it has a potential for oral ulceration and stomatitis
PMID: 14619897 [PubMed - indexed for MEDLINE]
Posted by KaraS on June 18, 2005, at 3:34:12
In reply to Re: Allergic to patch? » gromit, posted by KaraS on June 18, 2005, at 2:33:19
I was tired and for some reason I read the abstract as referring to the adverse effects of oral selegiline in terms of the diet.
Duh!
I'm going to sleep now.
Posted by ed_uk on June 18, 2005, at 9:33:11
In reply to Re: forget my last post!, posted by KaraS on June 18, 2005, at 3:34:12
Hi K!
>Would the sublingual selegiline also obviate the need for the MAOI diet?
Well.....it's only been studied at low doses - where dietary restrictions are unnecessary anyway. I'd expect sublingual seleg to potentiate the hypertensive effect of tyramine to a lesser extent that oral seleg because most of the seleg will bypass the gut when absorbed via this route. I suppose you'd have to be careful not to swallow any though!
I can't say the diet would be unnecessary with a high dose but I expect the chance of a hypertensive reaction would be somewhat reduced.
The bioavailability of the sublingual tablets is not the same as the oral tablets. For Parkinson's disease, the recommended dose of Zelapar is 1.25mg/day, as opposed to 10mg for the oral tabs.
RE the abstract from Prescrire Int. The journal is negative about EVERYTHING! I'm not kidding! I think they're just interested in health economics really.
Ed xxx
Posted by KaraS on June 18, 2005, at 16:06:45
In reply to Re: forget my last post! » KaraS, posted by ed_uk on June 18, 2005, at 9:33:11
> Hi K!
>
> >Would the sublingual selegiline also obviate the need for the MAOI diet?
>
> Well.....it's only been studied at low doses - where dietary restrictions are unnecessary anyway. I'd expect sublingual seleg to potentiate the hypertensive effect of tyramine to a lesser extent that oral seleg because most of the seleg will bypass the gut when absorbed via this route. I suppose you'd have to be careful not to swallow any though!
>
> I can't say the diet would be unnecessary with a high dose but I expect the chance of a hypertensive reaction would be somewhat reduced.
>
> The bioavailability of the sublingual tablets is not the same as the oral tablets. For Parkinson's disease, the recommended dose of Zelapar is 1.25mg/day, as opposed to 10mg for the oral tabs.
>
> RE the abstract from Prescrire Int. The journal is negative about EVERYTHING! I'm not kidding! I think they're just interested in health economics really.
>
> Ed xxx
Great answer! Thanks so much.K
Posted by Ktemene on June 19, 2005, at 11:13:12
In reply to Re: EMSAM(R) Approval timeline set, posted by Jakeman on June 17, 2005, at 20:56:32
Several people who tried the patch when it was in clinical trials said that the anxiety and insomnia from oral doses of Selegiline was much worse than the side effects of the patch. A dramatic reduction in anxiety and insomnia is one of the expected advantages of the patch.
> Several people on this board have reported adverse side effects from oral segiline, such as anxiety and insomnia. Does the patch improve on this kind of side effects?
>
> warm regards, ~ Jake
>
> > http://biz.yahoo.com/prnews/050616/lath022.html?.v=13
> >
> >
>
>
Posted by Ktemene on June 19, 2005, at 11:40:38
In reply to Re: Allergic to patch? » KaraS, posted by gromit on June 17, 2005, at 23:49:25
Even the sublingual selegiline is still ingested, and it is the ingesting part that causes the tyramine reaction. Of course, you could always try to spit out the sublingual selegiline, but it is unlikely that you would be able to get rid of all of it- some would still be going into your gut. The advantage of the patch is that the selegiline goes slowly and directly into the blood stream without going through the gut.
If you would like to try sublingual selegiline without paying for the liquid stuff, you could just get selegiline in capsule form. Open the capsule, and hold the powder in your mouth for a few moments. That is how I take my 5mg selegiline every day. The taste is not great, but the effect is the same as with Zydis selegiline.
On why the patch makes the diet restrictions unnecessary:
http://www.journals.elsevierhealth.com/periodicals/bps/article/PIIS0006322302018929/abstractAndrewB says that 2.5mg per day Selegiline will result in close to complete MAO-B inhibition.
http://www.dr-bob.org/babble/20010417/msgs/60824.htmlAdam says that 5mg per day will give near complete MAO-B inhibition.
http://www.dr-bob.org/babble/20010310/msgs/56813.html> > Would the sublingual selegiline also obviate the need for the MAOI diet? If so, then why do we need to wait for the patch at all? Maybe it's a lot harder to get doctors to prescribe the sublingual selegiline where as if the patch were released and promoted here, then mainstream doctors would be willing to prescribe it.
>
> I've wondered the same thing about sublingual selegiline, I know I've read that SHOULD be the case. I don't think there is a sublingual form available in the US. I imported some liquid, can't remember the measurement they use but I think it amounted to 300 mg, for about $90. Depending on your dose that could be pretty reasonable. At 10 mg a day it isn't, at least for me.
>
> I've searched for, but never found again a post where someone claimed a really low dose, like 1-2 mg a day, would eventually give almost complete inhibition.
>
>
> Rick
>
Posted by ed_uk on June 19, 2005, at 12:17:53
In reply to Re: Allergic to patch?, posted by Ktemene on June 19, 2005, at 11:40:38
>Even the sublingual selegiline is still ingested, and it is the ingesting part that causes the tyramine reaction. Of course, you could always try to spit out the sublingual selegiline, but it is unlikely that you would be able to get rid of all of it- some would still be going into your gut.
True indeed.......
~Ed
Posted by gromit on June 20, 2005, at 15:57:40
In reply to Re: Allergic to patch?, posted by Ktemene on June 19, 2005, at 11:40:38
> If you would like to try sublingual selegiline without paying for the liquid stuff, you could just get selegiline in capsule form. Open the capsule, and hold the powder in your mouth for a few moments. That is how I take my 5mg selegiline every day. The taste is not great, but the effect is the same as with Zydis selegiline.
Well the liquid stuff is not so pleasant either, but not horrible. The selegiline I got from my doctor was tablets, I guess you could crush them and do the same thing. The liquid did seem to be more potent. I think the post from AndrewB may be the one I was thinking of, thanks for the links.
Rick
This is the end of the thread.
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