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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 9 of 9. This is the beginning of the thread.
Posted by djmmm on February 2, 2007, at 12:49:37
Last week (I think) we had a discussion about Prestiq/FDA, etc...I found this article on Prestiq today...
Recycling Effexor?
Wyeth Depression Drug Wins Conditional U.S. ApprovalNEW YORK (Reuters) Jan 24 - Wyeth said on Tuesday U.S. regulators will approve its new Pristiq anti-depressant for adults if it fixes quality control problems at the plant where it is made to the satisfaction of federal inspectors.
Pristiq, also awaiting approval as a treatment for hot flashes related to menopause, is derived from Wyeth's $3.5 billion-a-year Effexor XR treatment.
Both drugs work by maximizing the presence of two brain-messenger chemicals, serotonin and norepinephrine.
Final approval of Pristiq also is contingent on other conditions, including Wyeth's commitment to perform studies of whether the medicine prevents relapses of depression and whether it is effective at low doses and in children, the company said.
But the studies do not need to be completed prior to approval of the new depression pill.
Wyeth has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments. But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.
Although Wyeth said the nausea tended to go away after the first week of treatment, it is now testing a low-dose 50 milligram version of Pristiq in hopes it will be better tolerated than doses of up to 400 milligrams used in large earlier depression studies.
The company on Tuesday said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes.
The FDA is scheduled to decide on the hot flashes indication in April.
"It all depends where we are on a host of things," a Wyeth spokeswoman said, referring to the time of launch.
A.G. Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 -- about $1 billion from use against depression and the remainder for menopausal symptoms.
But he said the estimate assumes Wyeth will aggressively try to switch depression patients from Effexor XR to Pristiq long before generic forms of Effexor XR come to market -- a strategy that Wyeth has not yet announced.
(Additional reporting by Bill Berkrot)
from Medscape
Posted by NYCguy on February 2, 2007, at 13:12:05
In reply to Pristiq..., posted by djmmm on February 2, 2007, at 12:49:37
Why would anyone take this Pristiq instead of Effexor XR? Is there any added benefit? Hopefully docs don't fall for this stupid money-grubbing scheme!
Posted by Phillipa on February 2, 2007, at 13:38:26
In reply to Re: Pristiq..., posted by NYCguy on February 2, 2007, at 13:12:05
With the rep effexor has who wants either unless you're one of the lucky it works for and then why change? Love Phillipa
Posted by ed_uk on February 2, 2007, at 14:31:19
In reply to Pristiq..., posted by djmmm on February 2, 2007, at 12:49:37
>Wyeth will aggressively try to switch depression patients from Effexor XR to Pristiq long before generic forms of Effexor XR come to market
This is the only reason for the existence of Pristiq. Money for Wyeth.
Ed
Posted by linkadge on February 3, 2007, at 9:29:17
In reply to Re: Pristiq... » djmmm, posted by ed_uk on February 2, 2007, at 14:31:19
It doesn't even have an attractive name. At least Effexor sounded like you were getting a powerful drug.
Pristiq sounds like the last name of the principle of a Brittish all girls boarding school.
Hello, my name is Elanor Pristiq and I run one of the finest boarding schools.....
Linkadge
Posted by ttee on February 3, 2007, at 15:29:32
In reply to Re: Pristiq..., posted by linkadge on February 3, 2007, at 9:29:17
Don't worry; Wyeth will pay millions to some psychiatric thought leaders to publish articles on the benefits of Pristiq over Effexor and other AD's. If that fails, they will come up with a valid reason why Effexor is suddenly less safe and the Pristiq will be void of the Effexor problem, whatever it is.
My guess is they will show that Pristiq will work at a lower dose than Effexor and eliminates a step in the metabolism process needed in Effexor, so they will publish that Pristiq has less nausea and discontinuation problems than with Effexor. Who wouldn't want to reduce the symptoms of Effexor withdrawal if you could (or are told you could) ?
Since Effexor has such a bad reputation, I think the Pristiq version will do even better in sales than the Lexapro vs. Celexa scam. Celexa didn't have a bad rep and look how well Lexapro did on fixing a problem that was not even there. Pristiq has the advantage of coming across as a solution to a very well known problem (Effexor).
I think Wyeth would be a good long term stock by due to Pristiq.
Posted by Quintal on February 3, 2007, at 16:27:10
In reply to Re: Pristiq..., posted by linkadge on February 3, 2007, at 9:29:17
>Hello, my name is Elanor Pristiq and I run one of the finest boarding schools.....
How do you do? My name is Penelope Pristique and I am the governess of Clarington Manor, the finest finishing school in Haughton County. We guaruntee superior results........
Q
Posted by djmmm on February 3, 2007, at 16:47:31
In reply to Re: Pristiq..., posted by ttee on February 3, 2007, at 15:29:32
> Don't worry; Wyeth will pay millions to some psychiatric thought leaders to publish articles on the benefits of Pristiq over Effexor and other AD's. If that fails, they will come up with a valid reason why Effexor is suddenly less safe and the Pristiq will be void of the Effexor problem, whatever it is.
>
> My guess is they will show that Pristiq will work at a lower dose than Effexor and eliminates a step in the metabolism process needed in Effexor, so they will publish that Pristiq has less nausea and discontinuation problems than with Effexor. Who wouldn't want to reduce the symptoms of Effexor withdrawal if you could (or are told you could) ?
>
> Since Effexor has such a bad reputation, I think the Pristiq version will do even better in sales than the Lexapro vs. Celexa scam. Celexa didn't have a bad rep and look how well Lexapro did on fixing a problem that was not even there. Pristiq has the advantage of coming across as a solution to a very well known problem (Effexor).
>
> I think Wyeth would be a good long term stock by due to Pristiq.
>Looking at some research on Desvenlafaxine, I read that the half life is only 2.1 hours... I figured that maybe it had a greater half life than Effexor, which is 5 or so hours (i could be wrong)....just read, Wyeth tested these doses :150, 225, 300, 450, 600, 750, and 900 mg all SLOW RELEASE.
(Clinical Pharmacology & Therapeutics (2005) 77, P28–P28; doi: 10.1016/j.clpt.2004.11.107)... it's also being marked for hot flashes.
Posted by linkadge on February 3, 2007, at 17:15:48
In reply to Re: Pristiq..., posted by djmmm on February 3, 2007, at 16:47:31
I didn't know what hot flashes were until I decided to quit effexor.
Linkadge
This is the end of the thread.
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