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Home Industry News Eli Lilly and Boehringer Ingelheim announce EC approval of Cymbalta

Eli Lilly and Boehringer Ingelheim announce EC approval of Cymbalta

22nd August 2008

Eli Lilly and Boehringer Ingelheim have announced the European Commission (EC) approval of Cymbalta (duloxetine) for generalised anxiety disorder (GAD).

The approval follows an initial positive opinion from the European Medicines Agence Commitee for Medicinal Products for Human Use, which was issued on June 26th of this year.

A total of five clinical studies of GAD led to the approval. These included four double-blind short-term and placebo-controlled trials in addition to a placebo-controlled relapse prevention study.

The drug was found to “significantly” improve core anxiety symptoms associated with GAD and measured using the Hamilton Anxiety Scale. Those who initially responded to duloxetine and were kept on it for six months showed a decrease in the likelihood of relapse in comparison to those taking the placebo.

Patients taking duloxetine also showed an improvement in role functioning, such as the ability to undertake home, work and social activities.

Side effects experienced included fatigue, drowsiness, constipation, nausea, hyperhidrosis and vomiting.

Eli Lilly explained that Cymbalta has already been approved for the treatment of diabetic peripheral neuropathic pain and major depressive disorder, the difference with GAD being that it is characterised by excessive worry and anxiety over a period of at least six months.

There are no known definitive causes for GAD but it has been linked to a variety of social and cultural factors.

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