![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 12 of 12. This is the beginning of the thread.
Posted by jrbecker on October 25, 2005, at 10:59:49
possibly sour news for EMSAM that might hurt its market launch....despite aggressive lobbying to prevent the need for a black-box warning on the drug's product label, members of the FDA panel have recommended just that....
This hearing will continue until tomorrow (26th), so the issue is not dead in the water. Also, there is a chance that Somerset might decide to launch the product anyways despite the scarlet letter of the black-box mandate.
Posted by jrbecker on October 25, 2005, at 11:34:04
In reply to FDA reviewer recommends blackbox warning for EMSAM, posted by jrbecker on October 25, 2005, at 10:59:49
newer, more expansive article...
UPDATE 2-Depression patch would need warning -US FDA staff
Tue Oct 25, 2005 11:47 AM ETBy Susan Heavey
WASHINGTON, Oct 25 (Reuters) - Low-dose versions of Somerset Pharmaceuticals Inc.'s proposed depression patch Emsam should carry a warning against eating certain foods while using the drug, U.S. regulatory staff said in documents made public on Tuesday.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the heart risks linked to its use with foods containing the compound tyramine, such as smoked meats and dairy products.
Because Emsam is delivered through the skin and does not need to be ingested, its manufacturer is seeking to avoid the so-called "black box" warning for its lowest proposed dose of 20 milligrams.
On Wednesday, a U.S. Food and Drug Administration advisory panel plans to discuss whether Emsam should also have to carry the warning. The agency usually follows the advice of its advisers, but not always.
"I do not advocate approval of the 20mg (milligram) Emsam patch without tyramine restrictions and recommend that the FDA proposed text for labeling this issue remain," FDA staff reviewer Greg Dubitsky wrote in documents released ahead of the meeting.
Somerset is a joint venture of Mylan Laboratories Inc. <MYL.N> and Watson Pharmaceuticals Inc. <WPI.N>. Bristol-Myers Squibb <BMY.N> holds U.S. and Canadian marketing rights for Emsam.
If approved, Emsam would be the first U.S.-approved skin patch to treat depression.
Shares of Mylan were up 3 cents at $21.13 in late morning trading while Watson shares were off 10 cents at $35.75. Shares of Bristol-Myers Squibb were up 19 cents at $21.83. All three companies trade on the New York Stock Exchange.
In separate documents released on Tuesday, the drugmakers said clinical data on more than 2,500 Emsam patients showed the drug was well tolerated without any dietary changes.
One study, in which patients taking the drug were encouraged to eat as much aged cheese as possible found they "could not eat enough to cause a significant increase in blood pressure," the documents said.
"The benefit of providing a new MAOI at an effective dose -- Emsam 20 mg -- that can safely be taken without dietary modifications ... outweighs the risk of inaccurate labeling that would discourage patients who would benefit from this medication," the companies said.
"We agree that the 30 and the 40 milligrams should have the dietary modifications, and we don't dispute that," Watson Pharmaceuticals spokeswoman Patty Eisenhaur told Reuters on Monday.
FDA's Dubitsky said people's sensitivity to tyramine in foods can vary widely and said there is a "need for a wide safety margin."
Somerset received conditional approval for the drug, known generically as selegiline, last year and sent the FDA additional data in June. A final decision is expected in late November.
Some analysts have set low expectations for the drug, which they expect will only be prescribed for hard-to-treat depression by psychiatrists rather than general physicians.
Prudential Equity group analysts David Woodburn and Christopher Karras said peak revenue may reach $50 million a year or less.
The documents were posted on the FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4186b2_index%20with%20disclaimer.htm
Posted by med_empowered on October 25, 2005, at 15:34:27
In reply to Re: FDA reviewer recommends ....update 1, posted by jrbecker on October 25, 2005, at 11:34:04
hmmm...since the FDA usually functions more as an industry-friendly group these days, if they're recommending a black box warning...that's a big deal. It makes me wonder about the quality of the data the company presented to them. Also...what's with the study where "patients were encouraged to eat as much aged cheese as possible" ? That kind of strikes me as a irresponsible and dangerous. Anyway, I'm just considerably less excited about this drug now than I was before..it seems more like a modest improvement on an old drug than some sort of innovative breakthrough. **sigh** with all the money drug companies make, you'd think they could do better.
Posted by ed_uk on October 25, 2005, at 16:01:54
In reply to FDA reviewer recommends blackbox warning for EMSAM, posted by jrbecker on October 25, 2005, at 10:59:49
I've gotta say, I don't think Emsam will be as effective as Nardil and Parnate :-(
~ed
Posted by cecilia on October 26, 2005, at 2:37:20
In reply to FDA reviewer recommends blackbox warning for EMSAM, posted by jrbecker on October 25, 2005, at 10:59:49
Anyone know what this means in terms of whether Emsam will actually become available? I'd heard that they weren't going to market it if the FDA imposed food restrictions but it sounds like they were planning to market the larger doses with food restrictions. I want to try this drug!!!!!! The side effects of Nardil and Parnate make then unusable for me. Fine if they want to put black box restrictions for food, they need to cover their you know what, but we all know, that regardless of what they put on their label, people won't need to be as cautious with Emsam as with traditional MAO's. Just the decreased anxiety from that would make a huge difference and it's supposed to have far fewer side effects. Cecilia
Posted by jrbecker on October 26, 2005, at 14:06:39
UPDATE 1-Data shows low-dose Emsam is safe - US FDA panel
Wed Oct 26, 2005 2:00 PM ETGAITHERSBURG, Md., Oct 26 (Reuters) - A low-dose version of Somerset Pharmaceuticals Inc.'s proposed Emsam depression patch can be safely used without a label warning against eating certain foods, a U.S. panel of health experts said on Wednesday.
Somerset, a joint venture of Mylan Laboratories Inc. <MYL.N> and Watson Pharmaceuticals Inc. <WPI.N>, is awaiting final U.S. Food and Drug Administration approval for the drug and is seeking to avoid a dietary warning for its lowest proposed dose of 20 milligrams.
Bristol-Myers Squibb <BMY.N> holds U.S. and Canadian marketing rights for Emsam.
The panel voted 7-4 that the low-dose version of Emsam could be used safely without the warning.
Mylan shares were up nearly 3 percent in afternoon trading, while Watson and Bristol-Myers shares were fractionally higher.
If approved, Emsam would be the first skin patch to treat depression on the market. It received conditional approval last year, and a final decision is expected in late November. The agency usually follows its advisers' advice.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the risk of high blood pressure when patients take it and eat smoked meats, dairy products and other foods containing the compound tyramine.
Somerset officials told panelists that because it is delivered through the skin and is not ingested, Emsam is safer. Their data showed its lowest proposed dose of 20 milligrams did not need the warning, but there was not enough data to consider waiving a warning for 30- or 40-milligram versions, they said.
In a second vote, the panelists narrowly decided that it would not be too confusing to have a warning on high-dose versions but not the low dose one. One panelist left the meeting early, making the second vote 6-4.
Shares of Mylan were up 60 cents at $21.59, Watson shares rose 8 cents at $35.73, and Bristol-Myers Squibb shares were up 11 cents at $21.76. All three stocks trade on the New York Stock Exchange.
Posted by jrbecker on October 26, 2005, at 14:08:42
In reply to Re: FDA reviewer recommends blackbox warning for EMSAM, posted by cecilia on October 26, 2005, at 2:37:20
sorry for the double post...
Posted by RobertDavid on October 26, 2005, at 22:12:00
In reply to FDA PANEL states no need for blackbox warning, posted by jrbecker on October 26, 2005, at 14:06:39
If the approve it next month, how long will it take till it's available?
Posted by Cecilia on October 27, 2005, at 3:12:29
In reply to FDA PANEL states no need for blackbox warning, posted by jrbecker on October 26, 2005, at 14:08:42
Now they say a decision won`t be made til late November! Somehow I was under the impression that the decision was to be made Oct. 26. WHY does it take so long? It`s not like it`s a new drug-selegiline has been around forever. Cecilia
Posted by ravenstorm on October 27, 2005, at 10:43:44
In reply to Re: FDA PANEL states no need for blackbox warning, posted by Cecilia on October 27, 2005, at 3:12:29
Posted by Psyc 1 on October 27, 2005, at 11:55:44
In reply to FDA reviewer recommends blackbox warning for EMSAM, posted by jrbecker on October 25, 2005, at 10:59:49
Assuming Emsam is approved in Nov., does anyone have a quess about how long it will be before it's actually available in pharmacies?
Posted by jclint on October 27, 2005, at 13:52:17
In reply to Re: FDA PANEL states no need for blackbox warning, posted by RobertDavid on October 26, 2005, at 22:12:00
This is very good news. I had almost given up on seeing it.
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
[email protected]
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.