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European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder

Friday, June 27, 2008 General News
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INDIANAPOLIS, June 27 Eli Lilly and Co(NYSE: LLY) and Boehringer Ingelheim today announced that the Committee forMedicinal Products for Human Use (CHMP) of the European Medicines Agency(EMEA) has issued a positive opinion supporting the approval of Cymbalta(R)(duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder(GAD).
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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 fourplacebo-controlled studies safety and efficacy were assessed. Duloxetinesignificantly improved core anxiety symptoms (as measured by the HamiltonAnxiety 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) (1,2,3,4) anddemonstrated improvement in role functioning, including ability to performeveryday activities in work, home and in social situations.(5,6) In addition,duloxetine significantly decreased the likelihood of relapse in those patientswho initially responded to duloxetine and were maintained on treatment for sixmonths compared with those switched to placebo.(7) The most common sideeffects in these studies included nausea, fatigue, dry mouth, drowsiness,constipation, insomnia, decreased appetite, hyperhidrosis, 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) Difficult to detect, due to the fact thatthe condition presents with a variety of symptoms,(11) GAD is characterised bymore than simple anxiety. The disorder is diagnosed when patients suffer fromexcessive anxiety and worry about a number of events and activities (such asperformance at work or school) over a sustained period of at least sixmonths.(12)

"If left untreated, symptoms of Generalised Anxiety Disorder may progressto prevent patients from working and operating in daily social situations,"said Dr. Christer Allgulander of the Department of Clinical Neuroscience,Karolinska Institutet in Stockholm. "According to population and primary caresurveys the majority of people suffering from anxiety, and their physicians,still have unmet needs. This positive opinion on duloxetine creates anothereffective pharmacotherapy option that will help patients feel better, and helpphysicians in their aim to improve functioning for those suffering from thisdebilitating condition."

Duloxetine, a member of a class of drugs commonly referred to as serotoninand noradrenaline reuptake inhibitors,(13) is already approved to treat majordepressive disorder and diabetic peripheral neuropathic pain. Duloxetinegained marketing authorisation for the treatment of GAD in Mexico in 2006 andin the United States in 2007.

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.(12) The illness tends to bechronic with periods of exacerbation and remission. Patients report thatepisodes of generalized anxiety disorder are often brought on, or worsened, bystressful life events.(14)

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
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