Wyeth to undertake further research to support desvenlafaxine approval

Wyeth Pharmaceuticals, a division of Wyeth, has confirmed that it is to undertake additional clinical studies to support European approval for desvenlafaxine as a potential treatment for vasomotor symptoms associated with menopause.

The pharmaceutical company will carry out further research to address questions put forward by the Committee for Medicinal Products for Human Use (CHMP) regarding the risk-benefit profile of desvenlafaxine.

Wyeth has also withdrawn its application for European Marketing Authorisation for desvenlafaxine until the studies have been completed.

Gary L Stiles, executive vice-president and chief medical officer at Wyeth Pharmaceuticals, commented: “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.”

He went onto highlight Wyeth’s commitment to developing the candidate, stating that the company believed desvenlafaxine could provide women with a “non-hormonal option to treat vasomotor symptoms”.

Last month, Wyeth’s head of global pharmaceuticals Joseph Mahady assured investors that interest in the company’s experimental drug portfolio would pick up ahead of forthcoming regulatory approvals of its new drug pipeline.