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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 12 of 12. This is the beginning of the thread.
Posted by bipolarspectrum on January 26, 2004, at 0:16:13
Hi,
Anyone know whether the FDA is planning on approving the selegiline transdermal patch???
And if so, anyone know of a general time frame?
Posted by theo on January 26, 2004, at 7:50:10
In reply to Transdermal Selegiline, aka. Selegiline Patch???, posted by bipolarspectrum on January 26, 2004, at 0:16:13
It flopped in testing transdermally, not much better than placebo. It could be a while. I was bumbed because I want to try an MAOI without all the diet restrictions.
Posted by polarbear206 on January 26, 2004, at 9:36:33
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch??? » bipolarspectrum, posted by theo on January 26, 2004, at 7:50:10
> It flopped in testing transdermally, not much better than placebo. It could be a while. I was bumbed because I want to try an MAOI without all the diet restrictions.
Thats funny because I just read about it in a february issue of a womens magazine (can't remember the name of the magazine, Womens Day maybe) that it will be FDA approved and on the market this spring. The name of the drug isn't the selegiline patch. It has another name though. I'm going to go to the store and get a copy and I'll be back with the facts for you.
Posted by mrporter1 on January 26, 2004, at 12:22:48
In reply to Transdermal Selegiline, aka. Selegiline Patch???, posted by bipolarspectrum on January 26, 2004, at 0:16:13
Hi...
Got this email from a friend who received it from her p-doc several weeks ago...
"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 bipolarspectrum on January 26, 2004, at 12:41:18
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch??? » bipolarspectrum, posted by mrporter1 on January 26, 2004, at 12:22:48
Hi,
Will it really takes month for the company to distribute the selegiline patch if its approved in Feb??? One would think that they would be ready to distribute right away?? I would love to get my hands on the patch as early as possible...
Posted by mrporter1 on January 26, 2004, at 15:06:28
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch???, posted by bipolarspectrum on January 26, 2004, at 12:41:18
> Hi,
> Will it really takes month for the company to distribute the selegiline patch if its approved in Feb??? One would think that they would be ready to distribute right away?? I would love to get my hands on the patch as early as possible...
>I think the doc said it would probably be out in 2005 - whole year! yikes!
Posted by noa on January 31, 2004, at 12:57:35
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch???, posted by mrporter1 on January 26, 2004, at 15:06:28
I just did a few minutes of searching on the web, and from what I gather, an announcement is expected around February 1st as to whether it will be approved or not. Apparently the product under review is called EMSAM(TM) (Selegiline Transdermal System) 20mg/20cm2. Made by Somerset Pharmaceuticals, which is jointly owned by Watson Pharmaceuticals and Mylan Labs.
As someone already said, when Straterra was approved, it took about 3 months to make it to market. But I don't know if that is the norm or not. I'm sure there are other posters here who are more familiar with how the process goes.
I hope it is approved. Although perhaps the trials have shown only moderate antidpressant results, veteran poster, Adam, who used to be a regular here at PB, and has stopped in occasionally over the years, was in the clinical trials for the patch and found good results from the patch for his depression, but had to give it up when the trial was over. He then switched to an oral MAOI.
http://www.dr-bob.org/babble/20000312/msgs/27239.html
The patch system for delivering the medication bypasses the problem associated with oral MAOIs, of having to have dietary restrictions to prevent hypertension problems, which aren't an issue at the low doses of oral Selegiline needed for Parkinsons Disease, but are an issue at the higher doses needed for depression.
Let's hope it is passed because even if it isn't the be-all-and-end-all great new antidepressant, it seems to me to be the first new/innovative thing for depression to come around in long time.
One question I do have is whether the selegiline patch can be combined with other meds safely, because it is obvious that many of us who have treatment resistant depression have not gotten enough results out of any single medication and have needed a combination approach to get results.
Posted by jrbecker on February 2, 2004, at 10:33:56
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch???, posted by noa on January 31, 2004, at 12:57:35
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.
Posted by Jonathan on February 2, 2004, at 14:09:54
In reply to Transdermal selegiline (EMSAM) marked approvable, posted by jrbecker on February 2, 2004, at 10:33:56
Posted by bipolarspectrum on February 2, 2004, at 23:59:03
In reply to Reboxetine (Vestra) marked approvable 3 YEARS AGO (nm), posted by Jonathan on February 2, 2004, at 14:09:54
Anyone know what the term 'approvable' actually means???
Does this imply that it is potentially approvable?
Posted by bruce1s on February 7, 2004, at 10:49:20
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch???, posted by noa on January 31, 2004, at 12:57:35
The FDA delivered an approvable letter right on schedule as someone on this site predicted a year ago.
My guess is the 2005 date is believable. When reading through all the articles on the web over the past several years I sense the medical community wants the patch to happen (not that the FDA cares or should care). And look at the new studies that are being run, e.g. for aids pts. etc. It's got the big Mo.
Once it is approved and marketed many will try it. All of us who are sick of SSRI side effects will beg our docs to give it a whirl. All the docs who have always been afraid of MAOIs will be tempted to give it a shot with their fat, sexless, (but somewhat happy) SSRI patients.
The success rate will probably be about the same as any other drug. But for that minority of pts who respond well and suffer fewer side effects it will be a great boon.
I'm going to try it asap. I think it will probably give me insomnia. But it's worth a try because Prozac makes life worth living at the cost of no sex and being fat--any drug that has even a 20% chance of improving any of these three variables looks very attractive.
Please keep us all informed of the progress on the patch.
Posted by noa on February 7, 2004, at 13:28:05
In reply to Re: Transdermal Selegiline, aka. Selegiline Patch?, posted by bruce1s on February 7, 2004, at 10:49:20
I discussed the EMSAM approvable status with my pdoc. It sounds like it wouldn't be a good risk for me because I'm on a combo of meds and it isn't clear yet if EMSAM can be combined safely with anything.
One of the reasons I have a combo is that Effexor is very activating for me so I can't take too much of it and have to balance it out with Serzone. From what I hear selegiline can also be quite activating, so I don't know if I could take it as monotherapy. I'd also probably have to discontinue the adderall. So this would mean going off all of my meds just to try the patch which may or may not work. Given the hassle of withdrawing from Effexor, the risk of the EMSAM not being effective for me, and the risk of going back on my old meds and not having them work as well the second go-round (this happened to me in the past with Prozac), I'd say I'm not going to be trying the EMSAM when it comes out.
I am *very* glad, however, to see that it will be coming onto market. A new way of delivering meds that could eliminate the main barrier for most people to MAOIs--this is a good development! But as my pdoc said---it's great to have a new mechanism for delivering medication, but what we really need to see is a med with a new mechanism of *action*. Still, I see the EMSAM approval as a good development.
Now, let's hope that we see that new mechanism of action developed in the near future!!
This is the end of the thread.
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