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The approval is based upon the results of five clinical studies of GAD-- four double-blind short-term (acute) placebo-controlled studies and aplacebo-controlled relapse prevention study -- involving more than 2,000non-depressed adults with GAD. In each of the four acute placebo-controlledstudies safety and efficacy were assessed. Duloxetine significantly improvedcore anxiety symptoms (as measured by the Hamilton Anxiety Scale) comparedwith placebo (p less than or equal to 0.001, p=0.02, p=0.007, p less than orequal to 0.001 respectively)(1,2,3,4) and patients demonstrated improvement inrole functioning, including ability to perform everyday activities in work,home and in social situations.(5,6) In addition, duloxetine significantlydecreased the likelihood of relapse in those patients who initially respondedto duloxetine and were maintained on treatment for six months compared withthose switched to placebo.(7) The most common side effects in these studiesincluded nausea, fatigue, dry mouth, drowsiness, constipation, insomnia,decreased appetite, hyperhidrosis (excessive perspiration), decreased libido,vomiting, ejaculation delay and erectile dysfunction.
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Although global prevalence is not currently known, more than nine millionEuropeans(8,9) and six million people in Central and South America areestimated to suffer from GAD(10), which is characterised by excessive anxietyand worry about a number of events and activities (such as performance at workor school) over a sustained period of at least six months.(11)
This regulatory approval paves the way for launches in Europe and appliesto all 27 countries of the European Union, as well as Norway, Iceland, andLiechtenstein.
Cymbalta(R), a member of a class of drugs commonly referred to asserotonin and noradrenaline reuptake inhibitors,(12) is already approved bythe EMEA to treat major depressive disorder and diabetic peripheralneuropathic pain. Duloxetine gained marketing authorisation for the treatmentof GAD in Mexico in 2006 and in the United States in 2007.
Notes to Editors:
About Generalised Anxiety Disorder
Approximately nine million Europeans(8,9) and six million people inCentral and South America are estimated to suffer from GAD.(10) Quality oflife is affected, as symptoms of GAD can include exaggerated worry or chronicanxiety, irritability and poor concentration. Ability to work is oftencompromised with the manifestation of physical symptoms such as muscletension, fatigue, sleep disturbance and nausea.(11) The illness tends to bechronic with periods of exacerbation and remission. Patients report thatepisodes of generalised anxiety disorder are often brought on, or worsened, bystressful life events.(13)
About Duloxetine
While duloxetine's mechanism of action in humans is not fully known, it isbelieved to affect both serotonin- and norepinephrine/noradrenaline-mediatednerve signalling in the brain and the spinal cord. Based on pre-clinicalstudies, duloxetine is a balanced and potent reuptake inhibitor of serotoninand norepinephrine/noradrenaline. Scientists believe that duloxetine's effectson mood and pain are due to an increase in the activity of serotonin andnorepinephrine in the central nervous system.
Duloxetine is approved for the treatment of depression and diabeticperipheral neuropathic pain in many countries and also approved in somecountries for the treatment of stress urinary
