Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim 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® (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?