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FDA Approves Extended Use Of Effexor (Venlaxafine HCl) For Treatment Of Depression MADISON, NJ -- May 9, 2001 -- American Home Products Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling for the prevention of major depressive disorder relapse for two versions of the company's antidepressant, venlafaxine HCl, marketed as Effexor® tablets and Effexor® XR extended-release capsules by Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP. The agency action was based on new data that demonstrated that venlafaxine was superior to placebo in preventing relapse, and demonstrated a significant reduction in recurrent episodes, both key factors in bringing patients to recovery. Wyeth-Ayerst submitted new labeling applications on May 5, 2000 (venlafaxine extended-release relapse) and May 18, 2000 (venlafaxine recurrence) based on data from two double-blind, randomized, placebo-controlled trials. The first trial, a six-month study of 318 people with depression, demonstrated that treatment with venlafaxine extended-release (at doses of 75mg, 150mg and 225mg per day) is significantly better than placebo at preventing relapse (the return of original symptoms of depression within four to six months of obtaining an initial treatment response). The second and longer trial, a 12-month study of 235 people with depression, demonstrated that treatment with venlafaxine showed a significant reduction in recurrent depressive episodes (new episodes of depression after a patient has recovered from a prior episode). "For over five years, venlafaxine extended-release has been helping millions of people with depression lead fuller lives," says Harold Marder, MD, Senior Vice President of Medical Affairs at Wyeth-Ayerst. "Today's new labeling approval from the FDA may help us provide the millions of Americans with depression not just relief from their symptoms, but also recovery, which is the optimal outcome of treatment. Physicians who prescribe Effexor or Effexor XR for long-term periods should periodically reevaluate the ongoing effectiveness of the drug for each individual patient." Major depressive disorder affects an estimated 340 million people worldwide. The World Health Organization recently concluded that depression is the world's fourth greatest public health problem. If left untreated, the effects of depression can be devastating, robbing people of the energy or motivation to perform everyday activities and, in some cases, leading to suicide. Symptoms of the disorder include feelings of sadness or emptiness, lack of interest or pleasure in nearly all activities, and feelings of worthlessness or inappropriate guilt. In addition to the personal costs of depression, the disorder also results in more than $40 billion in annual costs in the United States alone, due to premature death, lost productivity and absenteeism. SOURCE: American Home Products Corporation Related Links: Effexor (Venlaxafine HCl), American Home Products Corporation and Wyeth-Ayerst Laboratories. E-mail this page to a friend or colleague! To print, use this version