Cymbalta approved in Europe for generalised anxiety disorder

Aug 24 2008

Eli Lilly and Co and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD).

This approval -- the fourth for duloxetine in Europe -- was issued on 28 July following an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 26 June 2008.

The approval is based upon the results of five clinical studies of GAD -- four double-blind short-term (acute) placebo-controlled studies and a placebo-controlled relapse prevention study -- involving more than 2,000 non-depressed adults with GAD. In each of the four acute 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 patients 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. The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis (excessive perspiration), decreased libido, vomiting, ejaculation delay and erectile dysfunction.

Although global prevalence is not currently known, more than nine million Europeans and six million people in Central and South America are estimated to suffer from GAD, which is characterised by excessive anxiety and worry about a number of events and activities (such as performance at work or school) over a sustained period of at least six months.

This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the European Union, as well as Norway, Iceland, and Liechtenstein.

Cymbalta, a member of a class of drugs commonly referred to as serotonin and noradrenaline reuptake inhibitors, is already approved by the EMEA to treat major depressive disorder and diabetic peripheral neuropathic pain. Duloxetine gained marketing authorisation for the treatment of GAD in Mexico in 2006 and in the United States in 2007.