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:
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Menopause

Wyeth's Pristiq shows benefits in clinical trial

FDA demands more data on Wyeth's Pristiq