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news.Eli Lilly and Co and Boehringer Ingelheim have announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion supporting the approval of Cymbalta for the treatment of generalized anxiety disorder.
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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 generalized anxiety disorder. 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 and demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.
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.
Christer Allgulander of the Department of Clinical Neuroscience, Karolinska Institutet in Stockholm, said: “This positive opinion on duloxetine creates another effective pharmacotherapy option that will help patients feel better, and help physicians in their aim to improve functioning for those suffering from this debilitating condition.”