More Clinical Data Required to Support European Approval of Desvenlafaxine as a Potential Treatment for Vasomotor Symptoms
Madison, N.J. 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.
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