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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 20 of 20. This is the beginning of the thread.
Posted by bipolarspectrum on January 30, 2004, at 11:17:27
If the transdermal selegiline patch is approved this sunday (Feb.1) by the FDA, how long do you think until it is available... one would think that they would try to get it out as soon as possible to take advantage of the hype surrounding a new anti-depressant release... anyone had experience with the lag time between approval and drug availability for other drugs??
Posted by Chairman_MAO on January 30, 2004, at 12:16:13
In reply to IfTransdermal Selegiline is approved Sunday......., posted by bipolarspectrum on January 30, 2004, at 11:17:27
If my cynicism proves correct, the FDA will not approve this. Too many other psych drugs could be obsoleted by it, and I firmly believe the FDA is in the pocket of all major pharmaceutical companies. Think I'm paranoid? Then why is Eli Lilly exempt from civil action in the HOMELAND SECURITY BILL? If they have that level of power, corrupting the FDA would be child's play by comparison, no?
Let's hope I'm wrong about EmSam (transdermal selegiline).
--- from http://www.cbsnews.com/stories/2002/12/12/eveningnews/main532886.shtml --
(CBS) It's been a mystery in Washington for weeks. Just before President Bush signed the homeland security bill into law an unknown member of Congress inserted a provision into the legislation that blocks lawsuits against the maker of a controversial vaccine preservative called "thimerosal," used in vaccines that are given to children.
Drug giant Eli Lilly and Company makes thimerosal. It's the mercury in the preservative that many parents say causes autism in thousands of children – like Mary Kate Kilpatrick.
Asked if she thinks her daughter is a victim of thimerosal, Mary Kate's mother, Kathy Kilpatrick, says, "I think autism is mercury poisoning."
But nobody in Congress would admit to adding the provision, reports CBS News Correspondent Jim Acosta – until now.
House Majority Leader Dick Armey tells CBS News he did it to keep vaccine-makers from going out of business under the weight of mounting lawsuits.
"I did it and I'm proud of it," says Armey, R-Texas.
"It's a matter of national security," Armey says. "We need their vaccines if the country is attacked with germ weapons."
Rep. Dan Burton, R-Ind., isn't buying it. The grandfather of an autistic child, Burton says Armey slipped the provision in at the last minute, too late for debate.
"And I said, 'Who told you to put it in?'" He said, 'No, they asked me to do it at the White House.'"
Critics say the Bush family and the administration have too many ties to Eli Lilly. There's President Bush's father, who sat on the company's board in the 1970's; White House budget director Mitch Daniels, once an Eli Lilly executive; and Eli Lilly CEO Sidney Taurel, who serves on the president's homeland security advisory council.
Officials at the drug giant insist they did nothing wrong. "No one, not our CEO, not myself, not anyone who works with me asked the White House to insert this legislation," said Eli Lilly spokeswoman Debra Steelman.
But Kathy Kilpatrick and her husband Michael argue that the thimerosal provision is not designed to protect the nation, but rather to protect Eli Lilly.
Asked what he'd say to a congressman who came forward and admitted he was responsible for inserting the provision, Michael Kilpatrick says, "I would ask him if he knew he was protecting mercury being shot into our kids."
Kathy Kilpatrick asks, "Why would anyone want to save Eli Lilly on our children's backs?"
Because Armey is retiring at the end of the year, some say the outgoing majority leader is the perfect fall guy to take the heat and shield the White House from embarrassment.
It's a claim both the White house and Army deny.
Posted by bipolarspectrum on January 30, 2004, at 14:30:42
In reply to Re: IfTransdermal Selegiline is approved Sunday......., posted by Chairman_MAO on January 30, 2004, at 12:16:13
Hey,
Hmm, I can't help but think theres a little too much anti-FDA propaganda on this site.. I must remind you, I am Canadian and thus, have somewhat of an 'outside' (and possibly naive) view concerning the FDA... I believe the FDA will approve this patch as there is sufficient evidence that the patch is as irritating as a 'band-aid' and demonstrates increasing efficacy at higher doses... However, as the patch will be produced by a small, florida-based pharmaceutical company and could put a significant dent into the SSRI sales of the large american companies, you may be correct in stating that the those large companies may sway the FDA... But I maintain my faith in the american beaucratic system.. I guess we'll just have to wait and see..PS. I am really hoping that it is approved though, I think the patch could potentially provide a revolution similar to that of prozac's introduction back in the day..
Posted by rod on January 30, 2004, at 15:40:13
In reply to Re: IfTransdermal Selegiline is approved Sunday......., posted by Chairman_MAO on January 30, 2004, at 12:16:13
hmm, very interesting article Chairman_MAO.
But I have a question. Whats the deal with the transdermal selegiline? I mean ordinary selegiline is available for years and off patent, as far as i know. Is the transdermal form any better than the oral one? Or is it just a patentable form of selegiline? What about a extended release form of selegiline? Wouldnt that also work the same way?thanks
Roland
Posted by bipolarspectrum on January 30, 2004, at 16:11:15
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by rod on January 30, 2004, at 15:40:13
> hmm, very interesting article Chairman_MAO.
> But I have a question. Whats the deal with the transdermal selegiline? I mean ordinary selegiline is available for years and off patent, as far as i know. Is the transdermal form any better than the oral one? Or is it just a patentable form of selegiline? What about a extended release form of selegiline? Wouldnt that also work the same way?
>
> thanks
>
> RolandRoland,
Transdermal selegiline has been claimed by many to possibly be a new 'first-line' treatment for depression, ie. the first thing physicians may prescribe for depression... The transdermal has HUGE advantages over the oral form, such as NO dietary restrictions and significiant reducions in metabolite formation... An extended oral selegiline would have the same problems as regular oral selegiline: amphetamine production and dietary restrictions.. in conclusion, in my opinion, transdermal selegiline, if approved, may improve the lives of countless depression sufferers..
Posted by Questionmark on January 30, 2004, at 16:21:49
In reply to Re: IfTransdermal Selegiline is approved Sunday......., posted by Chairman_MAO on January 30, 2004, at 12:16:13
...That story and the thought of what you said being correct, which it probably is. Fury.
Posted by rod on January 30, 2004, at 16:39:10
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by bipolarspectrum on January 30, 2004, at 16:11:15
> > hmm, very interesting article Chairman_MAO.
> > But I have a question. Whats the deal with the transdermal selegiline? I mean ordinary selegiline is available for years and off patent, as far as i know. Is the transdermal form any better than the oral one? Or is it just a patentable form of selegiline? What about a extended release form of selegiline? Wouldnt that also work the same way?
> >
> > thanks
> >
> > Roland
>
> Roland,
> Transdermal selegiline has been claimed by many to possibly be a new 'first-line' treatment for depression, ie. the first thing physicians may prescribe for depression... The transdermal has HUGE advantages over the oral form, such as NO dietary restrictions and significiant reducions in metabolite formation... An extended oral selegiline would have the same problems as regular oral selegiline: amphetamine production and dietary restrictions.. in conclusion, in my opinion, transdermal selegiline, if approved, may improve the lives of countless depression sufferers..
ahh, thank you for the info! I didnt know about that.
But do you/someone know *why* there are few metabolites, no dietary restrictions? Does it bypass th liver and therefor does not get metabolized?Anyway, thanks for the info
Roland
Posted by bipolarspectrum on January 30, 2004, at 16:44:24
In reply to Re: IfTransdermal Selegiline is approved Sunday... » bipolarspectrum, posted by rod on January 30, 2004, at 16:39:10
Roland,
You are correct.. my going through the skin, the drug bypasses the so-called 'first-pass effect', which is a term used to describe the phenomen whereby a drug must bypass the liver and its metabolic enzymes before entering the bloodstream and reaching its target (assuming its target is not the liver or GI tract)... As oral selegiline is associated with high levels of amphetamine-like compounds due to first pass, administration via skin significantly reduces this and therefore reduces much of the 'side-effects' which are caused by the amphetamine-like compounds, such as jitteryness and insomnia..
As you may tell from my posts, I'm very excited about the potential benefit of transdermal selegiline..
Posted by rod on January 30, 2004, at 17:07:18
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by bipolarspectrum on January 30, 2004, at 16:44:24
Yeah, you really make me courios! I also looked some things on the net up. It really seems promising! I wasnt aware of the treatment option until now. I hope it will ever also come to europe. But I will try some ting else before. They discovered borna virus antibodies in my blood serum. But they are sending my serum to berlin to verify their results. hmm. Maybe thats the right way to go for me. Anyways
Thank you for the post!
Roland
Posted by rvanson on January 30, 2004, at 17:19:15
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by bipolarspectrum on January 30, 2004, at 16:11:15
I hope this Selegiline patch passes muster with the FDA but:
Does anyone realise that one of the metabolites of Selegiline is amphetamine?
Just a thought as many who have to take a drug test for work will not pass if they are on the patch.
Then you will have to inform the employer of your mental-health history, if you want to work, that is :(
Posted by bipolarspectrum on January 30, 2004, at 17:25:37
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by rvanson on January 30, 2004, at 17:19:15
Just to redirect the conversation, does anyone have an idea when the transdermal selegiline patch, if approved, will be available in an american pharmacy???
Anyone had previous experience with lag time between FDA approval and drug availability??
Im a canadian and I'm willing to drive to Florida on monday and knock on the door of the pharmaceutical company that produces selegiline..
Posted by Chairman_MAO on January 30, 2004, at 21:30:18
In reply to Re: IfTransdermal Selegiline is approved Sunday... » bipolarspectrum, posted by rod on January 30, 2004, at 16:39:10
The transdermal formulation is advantageous because it bypasses the gut, thereby not inhibiting MAO-A there, leaving it free to deaminate dietary tyramine. Drug-drug interactions still apply to the selegiline patch.
Posted by Chairman_MAO on January 30, 2004, at 21:37:50
In reply to Re: IfTransdermal Selegiline is approved Sunday..., posted by rvanson on January 30, 2004, at 17:19:15
No employer has a right to know WHY you are taking selegiline; a doctor's prescription is enough. Not only that, but commercially selegiline is sold as the levorotary isomer, which metabolizes into l-amphetamine and l-methamphetamine. L-methamphetamine is the same 'levmetamphetamine' (notice the deliberate misspelling to avoid idiotic paranoid people not using the product because it's 'amphetamine') that's included in VICKS NASAL INHALERS. It is d-amphetamine and d-methamphetamine that have the "abuse potential", e.g. actually are capable of raising mood the same day you take them. In the end, after you appeal the test results, you will never be found "guilty" of taking amphetamine if you're taking selegiline.
NOTE: d-selegiline, which you can't buy, is probably quite euphoric just as d-amphetamine is.
Posted by sb417 on January 31, 2004, at 0:11:39
In reply to IfTransdermal Selegiline is approved Sunday......., posted by bipolarspectrum on January 30, 2004, at 11:17:27
I have no idea. I'm just guessing. In the fall of 2002 (November, I believe) Strattera was approved by the FDA. It was available in pharmacies in early or mid-January of 2003.
Posted by bipolarspectrum on January 31, 2004, at 17:43:11
In reply to Two months, perhaps?, posted by sb417 on January 31, 2004, at 0:11:39
> I have no idea. I'm just guessing. In the fall of 2002 (November, I believe) Strattera was approved by the FDA. It was available in pharmacies in early or mid-January of 2003.
Two months would be awful!! I called somerset pharmaceuticals, the company which produces selegiline, and they told me that 'they couldn't tell me anything'... total bs!
Posted by sb417 on January 31, 2004, at 19:11:26
In reply to Re: Two months, perhaps?, posted by bipolarspectrum on January 31, 2004, at 17:43:11
Hi. I know two months would be awful, but as I said, I'm only guessing, based on what happened with another drug. I hope I'm wrong!
Posted by mrporter1 on February 1, 2004, at 1:36:46
In reply to IfTransdermal Selegiline is approved Sunday......., posted by bipolarspectrum on January 30, 2004, at 11:17:27
Hi...posted this a couple of times in past 6 months...
from a p-doc "in-the know" writing to a friend a month or so ago...
"As it turns out, I talked to my contact person this morning. He believes it
very likely that the selegiline patch will be approved by the FDA in
February and will be on the market in 2005. Of course, one cannot absolutely
count on any timeline (or anything at all, for that matter) when the FDA is
involved. I'm told that the data look very promising."
Posted by DissTired on February 2, 2004, at 8:44:49
In reply to IfTransdermal Selegiline is approved Sunday......., posted by bipolarspectrum on January 30, 2004, at 11:17:27
Any news on this?
> If the transdermal selegiline patch is approved this sunday (Feb.1) by the FDA, how long do you think until it is available... one would think that they would try to get it out as soon as possible to take advantage of the hype surrounding a new anti-depressant release... anyone had experience with the lag time between approval and drug availability for other drugs??
Posted by DissTired on February 2, 2004, at 9:00:23
In reply to News about patch (nm) » bipolarspectrum, posted by DissTired on February 2, 2004, at 8:58:50
Sorry the message above didn;t include my text for some reason.
Check this out..
Posted by jrbecker on February 2, 2004, at 10:37:02
In reply to Re: News about patch, posted by DissTired on February 2, 2004, at 9:00:23
Mylan Laboratories Inc. (MYL) And Watson Pharmaceuticals (WPI) Announce Receipt Of Approvable Letter For EMSAM
PITTSBURGH & CORONA, Calif.--(BUSINESS WIRE)--Feb. 2, 2004--Mylan Laboratories Inc. (NYSE:MYL - News) and Watson Pharmaceuticals, Inc. (NYSE:WPI - News) announced today that Somerset Pharmaceuticals, Inc. has received an "Approvable" letter from the U.S. Food and Drug Administration (FDA) for EMSAM(TM) (selegiline transdermal system), the company's transdermal therapy for which they are seeking an indication for the treatment of major depressive disorder. Somerset is a joint venture between Mylan and Watson.The FDA's letter indicates that Somerset has submitted sufficient data to support the efficacy of EMSAM (20mg, 30 mg & 40mg) in the acute and maintenance treatment of major depressive disorder. Somerset has initiated discussions with the FDA to review and clarify its comments. These comments include that Somerset conduct Phase 4 post-marketing pharmacokinetic and safety studies as well as additional pharmacology/toxicology studies. In addition, Somerset will initiate discussions with the FDA regarding proposed labeling, including FDA's request to include labeling addressing tyramine dietary restrictions while taking EMSAM.
"We will work diligently with the FDA on the specific additional requirements needed to obtain approval of our EMSAM(TM) product," said Mel Sharoky, M.D., Somerset's president and chief executive officer. "With over 2,000 depressed patients exposed to EMSAM, we are encouraged by the product's safety data and view EMSAM as an important advance in the treatment of depression. At the same time, Somerset will continue its discussions to out license EMSAM with a potential partner."
Mylan Laboratories Inc.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com.
Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com.
The parties caution that this press release may contain forward-looking statements, including with regard to EMSAM's safety and its role in the treatment of depression. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual future results may differ materially from those expressed or implied by such forward-looking statements due to such factors including, but not limited to, the results of the Phase 4 pharmacokinetic and safety studies and the additional pharmacology/toxicology studies, changing market conditions, the availability and cost of raw materials, the impact of competitive products and pricing, the timely development, FDA approval, and market acceptance of Somerset's and its competitors' products, the outcome of litigation and other risks detailed from time to time in the Securities and Exchange Commission filings of Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc. Except as required by law, the parties undertake no obligation to update these statements for revisions or changes after the date of this release.
Contact:
Mylan Laboratories Inc. Kris King, 724-514-1800 or Watson Pharmaceuticals, Inc. Patty Eisenhaur, 909-493-5611
Source: Mylan Laboratories Inc.
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