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Title: New Antidepressant Approved in Germany, Italy
URL: http://www.pslgroup.com/dg/4E80A.htm
Doctor's Guide
December 18, 1997


LONDON, ENGLAND -- December 18, 1997 -- Pharmacia & Upjohn's new antidepressant, Edronax Tablets (reboxetine tablets), has been approved for marketing in Germany and Italy.

Indicated for the acute treatment of depressive illness/major depression, Edronax was first approved in the United Kingdom in April 1997. Under the European Union's Mutual Recognition Procedure, with the U.K. as a reference member state, 11 EU member states agreed in October to grant marketing authorization to Edronax. In addition to Germany, Italy and the U.K., Edronax is also approved in Sweden, Denmark, Ireland, Austria and Finland.

Edronax belongs to a new class of antidepressants known as selective noradrenaline reuptake inhibitors. Deficiency of noradrenaline, a neurochemical that is released by one brain cell to signal another, is one of the key factors in the development of depressive illness. Edronax prevents cells from reabsorbing noradrenaline and depleting its supply in the brain.

The selective activity of Edronax on noradrenaline appears to help restore patients' energy and motivation for improved social functioning.

In controlled clinical studies with more than 2,000 patients, Edronax was shown to be effective in the acute treatment of depressive illness/major depression. Edronax was also shown to be effective for maintaining the clinical improvement in patients initially responding to treatment.

The most common side effects reported in the clinical trials were dry mouth, constipation, insomnia, increased perspiration and rapid heartbeat. In general, side effects associated with Edronax therapy were of mild to moderate severity, appeared early and tended to diminish with time.

Characterized by a sustained, morbid state of dejection and sadness, depression is a chronic and often recurring disorder with high levels of social and occupational impairment. According to a recent pan-European survey, 17 percent of the adult population in Europe had suffered from depression during the previous six-month period.

More information on: Pharmacia & Upjohn

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