MADISON, N.J., March 12 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it would need to conduct additional clinical studies to address questions from the Committee for Medicinal Products for Human Use (CHMP) regarding the risk-benefit profile of desvenlafaxine as a treatment for vasomotor symptoms. As a result, Wyeth voluntarily withdrew its application for European Marketing Authorisation for desvenlafaxine for the treatment of vasomotor symptoms (hot flashes) associated with menopause.
"We believe that desvenlafaxine can provide women with a non-hormonal option to treat vasomotor symptoms (VMS), and Wyeth remains committed to developing the molecule for this indication," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "Some of the questions raised by the CHMP can be addressed with our planned clinical trials, including the 12-month study Wyeth is initiating with post- menopausal women early this year. The Company also is considering whether to conduct additional studies."
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products and non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
W
'/>"/>
| SOURCE Wyeth Copyright©2008 PR Newswire. All rights reserved |