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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by law663 on December 6, 2005, at 1:40:12
Somerset Announces Revised FDA PDUFA Date for EMSAM(R) (Selegiline Transdermal System)
Monday November 21, 4:15 pm ETTAMPA, Fla., Nov. 21 /PRNewswire/ -- Somerset Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Division of Psychopharmacologic Drugs has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2006 for EMSAM® (selegiline transdermal system), an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder. The PDUFA goal date was extended by three months in order to allow the FDA sufficient time to review an amendment to Somerset's NDA submitted following the recommendations of the U.S. Food and Drug Administration's Psychopharmacologic Drug Advisory Committee.
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On October 26, 2005 the Psychopharmacologic Drug Advisory Committee voted EMSAM® (selegiline transdermal system) could be safely administered without tyramine dietary modifications at 20 mg. EMSAM 30 and 40 mg will be administered with tyramine dietary modifications as originally proposed by Somerset. The Committee also agreed that Somerset and Bristol-Myers Squibb could effectively communicate dietary instructions required at the higher doses, without requiring the same dietary instructions for the 20 mg dose. However, the FDA is not bound by the Committee's recommendations.EMSAM received an "approvable" letter from the FDA on January 30, 2004 and would be the first transdermal patch for the treatment of major depressive disorder upon final approval. EMSAM is an irreversible monoamine oxidase inhibitor that, when applied to the skin, is designed to deliver selegiline continuously over a 24-hour period. In December 2004, Somerset and Bristol- Myers Squibb entered into an agreement for the commercialization and distribution of EMSAM.
Somerset Pharmaceuticals, Inc. is a joint venture between Mylan Laboratories (NYSE: MYL - News) and Watson Pharmaceuticals, Inc. (NYSE: WPI - News). For more information about Somerset, visit www.somersetpharm.com.
Forward-Looking Statement
The parties caution that this press release may contain forward-looking statements, which 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, 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.
Posted by RobertDavid on December 6, 2005, at 22:23:56
In reply to Emsam expected 2/26/06, posted by law663 on December 6, 2005, at 1:40:12
I was disapointed to hear that news about further delays last month. I've been dying to be a "guinea pig", be first in line to try it. My doc thinks it's going to be great for many treatment resistent patients.
Gosh, it's been in the works since the late 90's. I've read many posts from people like Adam who responded so well to the patch (I wonder how he's doing, if he's still taking oral selegiline). There was so much excitement about a new option.
Who would have thought it would take this long to get a decision about an already approved drug, just delivered via a patch. Perhaps this is the end of the road and there will be an actual thumbs up or down in February. I understand it all just comes down to the food restriction requirements on the labeling.
If it's approved without the need to warn about food interaction BM & Mylan will probably work to make it available quickly. If they need to put food restriction warning on it I wonder if they will push it at all.
I sure wish there was a way to get something other than lip service from the FDA and drug companies about the approval status/process. Everyone I've talked with acts like they know the scoop, just say it. Like it's some big secret.
If it does come out, I just hope it will have been worth the wait, at least for some who haven't had luck with other meds.
Posted by law663 on December 6, 2005, at 23:38:08
In reply to The frustrations of waiting for EMSAM, posted by RobertDavid on December 6, 2005, at 22:23:56
It will come out. The FDA has ruled on the dietary restirction issue. The FDA is netoriously risk adverse, leading to obvious type II errors. If the FDA allows a drug on the market and it kills people, there's political hell to pay. But if it disallows a drug, there is little repercussion for all those that drug would have helped. Look at Vioxx: Hardly anyone speaks about the numerous people who are without a great drug despite the flimsy evidence that it was harmful.
That said, I think there's a good shot that Emsam will be out soon. Then we'll see if it lives uo to all of the hype.
> I was disapointed to hear that news about further delays last month. I've been dying to be a "guinea pig", be first in line to try it. My doc thinks it's going to be great for many treatment resistent patients.
>
> Gosh, it's been in the works since the late 90's. I've read many posts from people like Adam who responded so well to the patch (I wonder how he's doing, if he's still taking oral selegiline). There was so much excitement about a new option.
>
> Who would have thought it would take this long to get a decision about an already approved drug, just delivered via a patch. Perhaps this is the end of the road and there will be an actual thumbs up or down in February. I understand it all just comes down to the food restriction requirements on the labeling.
>
> If it's approved without the need to warn about food interaction BM & Mylan will probably work to make it available quickly. If they need to put food restriction warning on it I wonder if they will push it at all.
>
> I sure wish there was a way to get something other than lip service from the FDA and drug companies about the approval status/process. Everyone I've talked with acts like they know the scoop, just say it. Like it's some big secret.
>
> If it does come out, I just hope it will have been worth the wait, at least for some who haven't had luck with other meds.
Posted by Irish on December 20, 2005, at 15:00:51
In reply to The frustrations of waiting for EMSAM, posted by RobertDavid on December 6, 2005, at 22:23:56
Just for the jumping in, and for whatever it's worth...
You can compound the stuff yourself. The recipe is pretty easy...it's essentially powdered selegiline, plo gel and an occlusive dressing.
A desperate pal of mine did it after a clinical trial he was in ended. Seemed to have good results, and he didn't do food restrictions at a 30 mg dose.
Of course, I'm not a pharmacist and never played one on tv, so my information is about as trustworthy as an amateur gynocologists'.
Your mileage may vary.
Regards,
Alli
Posted by RobertDavid on December 20, 2005, at 16:47:13
In reply to Re: The frustrations of waiting for EMSAM, posted by Irish on December 20, 2005, at 15:00:51
Where would you buy plo gel and an occlusive dressing? I'd sure be interested from someone that is actually doing it.
How long has your pal been making his own patch and how did it compare to what he was getting?
This is the end of the thread.
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