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.

In addition, duloxetine significantly decreased the likelihood of relapse in those patients who initially responded to it and were maintained on treatment for six months compared with those switched to placebo. 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, the firm noted.