European Commission Approves Broader Depression Indication for Duloxetine
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European Commission Approves Broader Depression Indication for Duloxetine

NEW YORK -- December 10, 2009 -- The European Commission has approved a broader indication for duloxetine HCl (Cymbalta) from Major Depressive Episodes to Major Depressive Disorder.

The expanded indication, recommended in October by the Committee for Medicinal Products for Human Use (CHMP), means duloxetine may now be considered for use as long-term treatment in patients at higher risk of repeated depressive episodes.

The indication update was based on results from a long-term, placebo-controlled duloxetine depression study.

In the 52-week placebo-controlled maintenance phase, duloxetine-treated patients had a longer symptom-free period, and were less likely to experience a return of their depressive symptoms than patients who received placebo (rates of return of symptoms were 14.4% vs 33.1%, respectively).

SOURCE: Boehringer Ingelheim and Eli Lilly

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