Pristiq

FDA OKs Wyeth's antidepressant Pristiq

Mon, 03 Mar 2008 06:59:56 -0500

Wyeth announced late Friday that it won FDA approval for Pristiq, its next-generation version of the antidepressant Effexor. Wyeth was looking for an approval of Pristiq to offset the considerable losses that are likely to follow Effexor's loss of patent protection in 2010. Pristiq is a norepinephrine reuptake inhibitor, as is Effexor. But researchers say the drug can be used in therapeutic doses from the day it is prescribed, as opposed to the steadily ascending doses that doctors currently prescribe Effexor.

The approval came with strings. Wyeth has to conduct a string of trials covering long-term maintenance, sexual dysfunction, pediatric studies and lower-dose studies.

- here's the release on the approval
- read the report from TheStreet

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Wyeth presents Pristiq data

Wed, 12 Dec 2007 06:59:55 -0500

Wyeth is revealing more Pristiq data today from two Phase III clinical studies of Pristiq. Earlier this year, the FDA issued an approvable letter for Pristiq, delaying the launch of the drug for major depressive disorder. The data showed that patients who received a 50 mg/day dose of the drug for MDD experienced a statistically significant reduction in the symptoms of major depression compared to placebo.

Wyeth, which has had several promising drugs fizzle out this year, says the data has been submitted to the FDA. The agency is expected to make a decision on the drug in the first quarter of 2008.

- see this release from Wyeth

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Wyeth's Pristiq shows benefits in clinical trial

Mon, 15 Oct 2007 06:59:55 -0400

Wyeth says that the nonhormonal desvenlafaxine, or Pristiq, demonstrated significant efficacy against hot flashes and night sweats in a clinical trial--but noted that high blood pressure and other troubling side effects were also seen in the data. Wyeth shares tumbled nine percent last July when the feds announced that they couldn't approve Pristiq without another trial on the heart and liver risks patients might be exposed to.

"There are more than 10 million menopausal women who experience moderate to severe hot flashes and night sweats. Only a small percentage of menopausal women use FDA-approved treatments, all of which are hormone-based," says Ginger Constantine, M.D., Vice President, Women's Health Care, Wyeth Pharmaceuticals. "Wyeth is committed to continuing to develop desvenlafaxine as a potential non-hormonal treatment option for women with moderate to severe vasomotor symptoms associated with menopause."

- here's the release for more info

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Read more on: Wyeth

FDA demands more data on Wyeth's Pristiq

Tue, 24 Jul 2007 06:59:58 -0400

Wyeth was effectively stiff-armed by the FDA in its application for Pristiq, the first non-hormonal therapy to treat menopausal symptoms. In an approvable letter, regulators told the company that they want to see a one-year safety study done to gather more data on how the drug could affect patients' hearts and livers. That amounts to a major delay for Wyeth, but the drug company shows no sign of backing away from the therapy.

"Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," said Wyeth CMO Dr. Gary Stiles. "We will work with the agency, and we have not yet met with them, to satisfy its requests for additional data and move this medicine forward in the FDA review process."

- see the release
- check out the AP report for more

Related Articles:
Wyeth expects provisional OK for Pristiq. Report
FDA approves Pristiq for depression. Report