Cymbalta gets nod for GAD in European

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of German drug major Boehringer Ingelheim's Cymbalta (duloxetine HCl) for generalized anxiety disorder.

The opinion is based on the results of five clinical studies - four double-blind placebo-controlled trials 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) and demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.