2007-02-26

U.S. Regulators Approve Cymbalta(R) for Treatment of Generalised Anxiety Disorder


Indianapolis (ots/PRNewswire) -

The U.S. Food and Drug Administration (FDA) has approved theantidepressant Cymbalta(R) (duloxetine HCl) for the treatment ofgeneralised anxiety disorder (GAD), Eli Lilly and Company (NYSE: LLY)and Boehringer Ingelheim announced today.

The approval is based on the results of three randomized,double-blind, placebo-controlled studies in which the safety andefficacy of duloxetine in the treatment of GAD was studied in morethan 800 non-depressed adults. In all studies, duloxetinesignificantly improved core anxiety symptoms as measured by theHamilton Anxiety Scale (HAMA), compared with placebo.(i,ii ,iii) Inaddition, duloxetine patients reported greater improvement infunctional impairment associated with the illness, including improvedability to perform everyday activities at work, home, and in socialsituations.(iv,v)

Duloxetine, a member of a class of drugs commonly referred to asserotonin and norepinephrine reuptake inhibitors (SNRI),(vi) wasapproved by Mexico for the treatment of GAD in October 2006. Lillyand Boehringer Ingelheim, which partner in the development andcommercialization of duloxetine for neuroscience indications in mostcountries outside the United States and Japan, are evaluating furthersubmissions in other regions, including Europe.

More than 7 million Europeans may have generalised anxietydisorder.(vii,viii) Worldwide prevalence is not known. While anxietyis a symptom of many mental health disorders, including depression,GAD is more than simple anxiety. The essential feature of thedisorder is excessive anxiety and worry about a number of events andactivities (such as work or school performance), occurring for amajority of days for at least six months.(ix) Because GAD presentswith a variety of symptoms, both anxious and physical, it can bedifficult to diagnose(x) and may have a negative impact on a person'squality of life(xi) and ability to work.(xii) Symptoms can includeexaggerated worry or chronic anxiety and irritability, which can leadto poor concentration and procrastination, as well as physicalsymptoms such as muscle tension, fatigue and nausea. Episodes ofgeneralised anxiety disorder may be brought on, or worsened by,stressful life events. The illness also tends to be chronic withperiods of exacerbation and remission.

In a pooled analysis of the three clinical trials supporting theapproval, on average, patients treated with duloxetine forgeneralised anxiety disorder experienced a 46 percent improvement inanxiety symptoms compared with 32 percent for those who took placebo,as measured by the Hamilton Anxiety Scale (p<=0.001).(xiii,xiv,xv) Inaddition, patients in these studies experienced a 46 percentimprovement in function, as measured by the Sheehan Disability Scale,compared with 26 percent for those who took placebo(p<=0.001).(xvi,xvii) The most common side effects in these studiesincluded nausea, fatigue, dry mouth, drowsiness, constipation,insomnia, decreased appetite, hyperhidrosis, decreased libido,vomiting, ejaculation delay and erectile dysfunction.

Notes to Editors:

About Duloxetine

Duloxetine is believed to potentiate both serotonin andnorepinephrine/noradrenaline in the brain and the spinal cord,impacting nerve signaling. Based on pre-clinical studies, duloxetineis a balanced and potent reuptake inhibitor of serotonin andnorepinephrine/noradrenaline. While the mechanism of action ofduloxetine in humans is not fully known, scientists believe itseffect on pain perception is due to increasing the activity ofserotonin and noradrenaline in the central nervous system.

Duloxetine is approved for the treatment of depression anddiabetic peripheral neuropathic pain in many countries and isapproved in some countries for the treatment of stress urinaryincontinence. Duloxetine is approved only for adults 18 and over. Inchildren and teens, antidepressants can increase the risk of suicidalthoughts or actions. Patients should call their doctor right away ifthey experience worsening depression symptoms, unusual changes inbehavior or thoughts of suicide, especially at the beginning oftreatment or after a change in dose.

The most commonly reported adverse reactions in patients withdepression treated with duloxetine in clinical trials were headache,nausea, dry mouth and constipation. However, the majority of commonadverse reactions were mild to moderate, they usually started earlyin therapy and most tended to subside even as therapy was continued.The most commonly observed adverse reactions in patients withdiabetic neuropathic pain treated with duloxetine were: nausea;somnolence; dizziness; and headache.

Duloxetine is contraindicated in patients who are allergic to it,who have liver disease resulting in hepatic impairment, who aretaking a monoamine oxidase inhibitor (MAOI), fluvoxamine,ciprofloxacin or enoxacine or who have severe kidney disease.

Eli Lilly and Company and Boehringer Ingelheim

In November 2002, Eli Lilly and Company and Boehringer Ingelheimsigned a long-term agreement to jointly develop and commercializeduloxetine hydrochloride. This partnership covers neuroscienceindications in most countries outside of the United States and Japan,with few exceptions.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories andfrom collaborations with eminent scientific organizations.Headquartered in Indianapolis, Ind., Lilly provides answers - throughmedicines and information - for some of the world's most urgentmedical needs. Additional information about Lilly is available atwww.lilly.com.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 143 affiliates in 47 countries and almost37,500 employees. Since it was founded in 1885, the family-ownedcompany has been committed to researching, developing, manufacturingand marketing novel products of high therapeutic value for human andveterinary medicine. In 2005, Boehringer Ingelheim posted net salesof 9.5 billion euro while spending almost one fifth of net sales inits largest business segment Prescription Medicines on research anddevelopment. For more information please visitwww.boehringer-ingelheim.com.

Duloxetine for major depressive episodes is marketed by Lilly andBoehringer Ingelheim in all countries included in the partnershipunder the brand name Cymbalta, except for Greece, Italy and Spain. InGreece, Italy and Spain Lilly markets the product as Cymbalta andBoehringer Ingelheim markets the product as Xeristar(R). In theUnited States, Cymbalta is marketed by Lilly and Quintiles. In Japan,duloxetine will be co-developed and co-marketed by Lilly and Shionogi& Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lillyunder the brand name Yentreve.(R)

i Koponen H., et al. Efficacy of Duloxetine for the Treatment of Generalized Anxiety Disorder: Implications for Primary Care Physicians. Primary Care Companion to The Journal of Clinical Psychiatry. In press 2007. ii Rynn M., et al. Efficacy and Safety of Duloxetine in the Treatment of Generalized Anxiety Disorder: A Flexible-Dose, Progressive-Titration, Placebo-Controlled Trial. Depression and Anxiety. In press 2007. iii Hartford J., et al. Duloxetine as an SNRI Treatment for Generalized Anxiety Disorder: Results from a Placebo- and Active-Controlled Trial. International Clinical Psychopharmacology. In press 2007. iv Endicott J., et al. Duloxetine Treatment for Role Functioning Improvement in Generalized Anxiety Disorder: Three Independent Studies. The Journal of Clinical Psychiatry. In press 2007. v Allgulander C., et al. Pharmacotherapy of Generalized Anxiety Disorder: Results of Duloxetine Treatment from a Pooled Analysis of 3 Clinical Trials. Current Medical Research and Opinion. In press 2007. vi Bymaster, FP et al. "The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression." Current Pharmaceutical Design. 2005; 11: 1475-1493. vii Lieb R, Becker E and Altamura C. The epidemiology of generalised anxiety disorder in Europe. European Neuropsychopharmacology 2005 Aug; 15(4): 445-52. viii National Institute of Economic and Social Research. Summarized from the National Institute Economic Review, 194, 28 October 2005. ix American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, p 472. x Gliatto, Michael, F. "Generalised Anxiety Disorder." American Family Physicians, Vol. 62/No. 7, October 1, 2000. xi Mendlowicz, Maura V. and Stein, Murray B. "Quality of Life in Individuals with Anxiety Disorders." American Journal of Psychiatry, Vol. 157/No. 5, May 2000, pp 677-678 xii Eric R. Henning, M.A., Cynthia L. Turk, Ph.D. , Douglas S. Mennin, Ph.D. , David M. Fresco, Ph.D., Richard G. Heimberg, Ph.D. Impairment and quality of life in individuals with generalised anxiety disorder. Depression and Anxiety 2006 Nov: 1091-4269 xiii Koponen H., et al. Efficacy of Duloxetine for the Treatment of Generalized Anxiety Disorder: Implications for Primary Care Physicians. Primary Care Companion to The Journal of Clinical Psychiatry. In press 2007. xiv Rynn M., et al. Efficacy and Safety of Duloxetine in the Treatment of Generalized Anxiety Disorder: A Flexible-Dose, Progressive-Titration, Placebo-Controlled Trial. Depression and Anxiety. In press 2007. xv Hartford J., et al. Duloxetine as an SNRI Treatment for Generalized Anxiety Disorder: Results from a Placebo- and Active-Controlled Trial. International Clinical Psychopharmacology. In press 2007. xvi Endicott J., et al. Duloxetine Treatment for Role Functioning Improvement in Generalized Anxiety Disorder: Three Independent Studies. The Journal of Clinical Psychiatry. In press 2007. xvii Allgulander C., et al. Pharmacotherapy of Generalized Anxiety Disorder: Results of Duloxetine Treatment from a Pooled Analysis of 3 Clinical Trials. Current Medical Research and Opinion. In press 2007. (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) (Logo: http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO )

ots Originaltext: Boehringer Ingelheim GmbH and Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de

Contact:David Shaffer, Eli Lilly and Company, +1-317-651-3710; or Ute E. Schmidt, Boehringer Ingelheim, +49-6132-77-97296/ Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO , http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO , PRN Photo Desk,photodesk@prnewswire.com

Boehringer Ingelheim GmbH and Eli Lilly and Company

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U.S. Regulators Approve Cymbalta(R) for Treatment of Generalised Anxiety Disorder

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