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
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thread:729070
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