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European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder
Date:6/26/2008

INDIANAPOLIS, June 27 /PRNewswire-FirstCall/ -- Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of Cymbalta(R) (duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder (GAD).

The positive opinion is based upon the results of five clinical studies -- four double-blind placebo-controlled studies and a relapse prevention study -- involving more than 2,000 non-depressed adults with GAD. In each of the four placebo-controlled studies safety and efficacy were assessed. Duloxetine significantly improved core anxiety symptoms (as measured by the Hamilton Anxiety Scale), compared with placebo (p less than or equal to 0.001, p=0.02, p=0.007, p less than or equal to 0.001 respectively) (1,2,3,4) and demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.(5,6) In addition, duloxetine significantly decreased the likelihood of relapse in those patients who initially responded to duloxetine and were maintained on treatment for six months compared with those switched to placebo.(7) The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.

Although global prevalence is not currently known, more than nine million Europeans (8,9) and six million people in Central and South America are estimated to suffer from GAD.(10) Difficult to detect, due to the fact that the condition presents with a variety of symptoms,(11) GAD is characterised by more than simple anxiety. The disorder is diagnosed when patients suffer from excessive anxiety and worry about a number of events and activities (such as performance at work or school) over a
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SOURCE Eli Lilly and Company
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