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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by jrbecker on February 2, 2004, at 10:32:27
http://www.biospace.com/news_story.cfm?StoryID=15019720&full=1
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 Chairman_MAO on February 2, 2004, at 11:20:23
In reply to Transdermal selegiline (EMSAM) marked approvable, posted by jrbecker on February 2, 2004, at 10:32:27
I'm pleased that my cynicism wasn't correct and this was approved. I will be one of the first people in the EmSam line when it hits pharmacies. Finally, we are moving beyond first generation MAO inhibitors in the US. Only took five decades!
BTW, has anyone here ever supplemented selegiline with raw cacao powder (as a source of phenethylamine, which is extremely hard to buy unless you are a research institution)? I bought it in capsules (Nature's Way) and found that a few grams of cacao combined with selegiline produced a pleasant, amphetamine-like effect without the sympathetic nervous system activation.
I will no doubt be eating more chocolate when that patch rests upon my body. :)
Sustained antidepressant
effect of PEA replacement
by
Sabelli H; Fink P; Fawcett J; Tom C
Rush University and the Center for
Creative Development, Chicago, Illinois, USA.
J Neuropsychiatry Clin Neurosci, 1996 Spr, 8:2, 168-71ABSTRACT
Phenylethylamine (PEA), an endogenous neuroamine, increases attention and activity in animals and has been shown to relieve depression in 60% of depressed patients. It has been proposed that PEA deficit may be the cause of a common form of depressive illness. Fourteen patients with major depressive episodes that responded to PEA treatment (10-60 mg orally per day, with 10 mg/day selegiline to prevent rapid PEA destruction) were reexamined 20 to 50 weeks later. The antidepressant response had been maintained in 12 patients. Effective dosage did not change with time. There were no apparent side effects. PEA produces sustained relief of depression in a significant number of patients, including some unresponsive to the standard treatments. PEA improves mood as rapidly as amphetamine but does not produce tolerance.
Posted by Jaynee on February 2, 2004, at 13:03:56
In reply to Re: Transdermal selegiline (EMSAM) marked approvable, posted by Chairman_MAO on February 2, 2004, at 11:20:23
I am curious to know if it is activating or sedating. I suffer from anxiety more than anything else, so I am hoping maybe this will help with anxiety type depression.
Posted by rvanson on February 3, 2004, at 2:34:08
In reply to Is (EMSAM) activating or sedating...., posted by Jaynee on February 2, 2004, at 13:03:56
> I am curious to know if it is activating or sedating. I suffer from anxiety more than anything else, so I am hoping maybe this will help with anxiety type depression.
It will be activating for most people would be my guess.
YMMV.
Posted by noa on February 3, 2004, at 12:14:18
In reply to Transdermal selegiline (EMSAM) marked approvable, posted by jrbecker on February 2, 2004, at 10:32:27
Hmm...I don't know the lingo well enough. "Approvable"---it seems to imply that they passed one hurdle and are moving on to the next---having to do more studies on safety, etc. Does this mean they only just passed the hurdle of proving efficacy?
I was interested in the statement in the press release you posted about dietary issues related to tyramine. I thought that these were sidestepped by the transdermal delivery of the medication. I guess maybe I was wrong. But I do wonder about interactions with other meds, ie, will EMSAM be a med that can be combined safely with others or not.
Well, it seems like there is still a ways to go in this process, but at least it's moving forward.
Posted by SLS on February 3, 2004, at 14:51:22
In reply to Re: Transdermal selegiline (EMSAM) marked approvable » jrbecker, posted by noa on February 3, 2004, at 12:14:18
> Hmm...I don't know the lingo well enough. "Approvable"---it seems to imply that they passed one hurdle and are moving on to the next
Hi Noa.
I think "approvable" means that it passed the tests for safety and efficacy. No more studies are needed. Usually, there are some issues with wording of the label and manufacturing facility. This is what has hindered Lilly from marketing duloxetine (Cymbalta).
- Scott
Posted by noa on February 3, 2004, at 15:29:36
In reply to Re: Transdermal selegiline (EMSAM) marked approvable, posted by SLS on February 3, 2004, at 14:51:22
Thanks, Scott. But the press release seemed to suggest that they have to do more safety tests.
What is the final approval designation once the labeling issues are resolved?
Posted by Chairman_MAO on February 3, 2004, at 18:57:49
In reply to Re: Transdermal selegiline (EMSAM) marked approvable, posted by noa on February 3, 2004, at 15:29:36
If I recall correctly, the press relese mentioned "post-marketing" studies. That is, after it hits the market. Am I right?
Posted by noa on February 3, 2004, at 20:02:15
In reply to Re: Transdermal selegiline (EMSAM) marked approvable » noa, posted by Chairman_MAO on February 3, 2004, at 18:57:49
Yes, I just went back to read the release again--it is referring to post-marketing studies, as well as to some issues about labelling. But hopefully they are ok to go to market.
Posted by Dreaman on February 4, 2004, at 21:22:37
In reply to Re: Transdermal selegiline (EMSAM) marked approvable » Chairman_MAO, posted by noa on February 3, 2004, at 20:02:15
Question, will EMSAM only be offered in 20 mg patches at first or will they offer lesser amounts as well.
*Dreaman
This is the end of the thread.
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