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

General Press Releases Friday June 27, 2008 07:48

Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim today 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(R) (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 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) and demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.(5,6) 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.(7) The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.

Although global prevalence is not currently known, more than nine million Europeans (8,9) and six million people in Central and South America are estimated to suffer from GAD.(10) Difficult to detect, due to the fact that the condition presents with a variety of symptoms,(11) GAD is characterised by more than simple anxiety. The disorder is diagnosed when patients suffer from

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.(12)

"If left untreated, symptoms of Generalised Anxiety Disorder may progress to 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 care surveys the majority of people suffering from anxiety, and their physicians, still have unmet needs. This positive opinion on duloxetine creates another effective pharmacotherapy option that will help patients feel better, and help physicians in their aim to improve functioning for those suffering from this debilitating condition."

Duloxetine, a member of a class of drugs commonly referred to as serotonin and noradrenaline reuptake inhibitors,(13) is already approved 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.

Notes to Editors:
About Generalised Anxiety Disorder

Approximately nine million Europeans (8,9) and six million people in Central and South America are estimated to suffer from GAD.(10) Quality of life is affected as symptoms of GAD can include exaggerated worry or chronic anxiety, irritability and poor concentration. Ability to work is often compromised with the manifestation of physical symptoms such as muscle tension, fatigue, sleep disturbance and nausea.(12) The illness tends to be chronic with periods of exacerbation and remission. Patients report that

episodes of generalized anxiety disorder are often brought on, or worsened, by stressful life events.(14)
About Duloxetine

While duloxetine's mechanism of action in humans is not fully known, it is believed to affect both serotonin and orepinephrine/noradrenaline mediated nerve signalling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe its effect on pain

perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved for the treatment of depression and diabetic peripheral neuropathic pain, in many countries and is approved in some countries for the treatment of stress urinary incontinence, Major Depressive Disorder and Generalized Anxiety Disorder. Duloxetine is approved only for adults 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they

experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.
Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:
-- For depression: Nausea, dry mouth, headache, insomnia, diarrhea
-- For diabetic peripheral neuropathic pain: Nausea, somnolence (sleepiness), fatigue, headache, dizziness
-- For stress urinary incontinence: Nausea, dry mouth, fatigue
-- For Generalised Anxiety Disorder: Nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.
(This is not a complete list of side effects.)

Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose

them to a potential risk of hypertensive crisis.
Eli Lilly and Company and Boehringer Ingelheim

In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications 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 a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high

therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.co.uk.

Duloxetine for major depressive episodes is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar(R). In the United 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 Lilly under the brand name Yentreve.(R)
References
(1) Koponen, H., et al. Efficacy of Duloxetine for the Treatment of
Generalized Anxiety Disorder: Implications for Primary Care Physicians. Prim
Care Companion J Clin Psychiatry 2007: 9(2):100-107
(2) 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 2007: 25(3): 182-189.
(3) Hartford, J., et al. Duloxetine as an SNRI Treatment for Generalized
Anxiety Disorder: Results from a Placebo- and Active-Controlled Trial. Int
Clin Psychopharmacol 2007: 22(3):167-74.
(4) Nicolini H, et al. Improvement of psychic and somatic symptoms in
adult patients with generalized anxiety disorder: Examination from a
duloxetine, venlafaxine extended-release, and placebo-controlled study. In
Press at Psychological Medicine.
(5) Endicott, J., et al. Duloxetine Treatment for Role Functioning
Improvement in Generalized Anxiety Disorder: Three Independent Studies. The
Journal of Clinical Psychiatry 2007: 68(4):518-24
(6) 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 2007: 23(6): 1245-1252
(7) Davidson JRT, et al. Duloxetine treatment for relapse prevention in
adults with generalized anxiety disorder: A 26-
week randomized placebo-controlled study. Poster presented at the American
College of Neuropsychopharmacology annual conference 2007. Boca Raton,
Florida
(8) Lieb, R, et al. The epidemiology of generalised anxiety disorder in
Europe. European Neuropsychopharmacology 2005 Aug;15(4):445-52.
(9) National Institute of Economic and Social Research. Summarized from
the National Institute Economic Review,194, 28 October 2005.
(10) Calculated extrapolations of prevalence rates against the populations
of a particular country or region, based upon prevalence of generalized
anxiety disorder in the US, UK, Canada or Australia. Available at:
http://www.cureresearch.com/g/generalized_anxiety_disorder/stats-country.htm.
Accessed on 2.4.08
(11) Gliatto, M.F. Generalised Anxiety Disorder. American Family
Physicians, Vol. 62/No. 7, October 1, 2000.
(12) National Institute of Mental Health (NIMH). Anxiety Disorders.
Available at:
http://www.nimh.nih.gov/health/publications/anxiety-disorders/generalized-
anxiety-disorder-gad.shtml. Accessed on 2.5.08
(13) 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.
(14) Patient.co.uk. Generalized anxiety disorder. Available at
http://www.patient.co.uk/showdoc/27000122/. Accessed on 2.5.08
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
CONTACT: Charles McAtee of Eli Lilly and Company,
+1-317-277-1566; or
Eva Freitag of Boehringer Ingelheim,
+ 49 (6132) 77-2964
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
--Distributed by AsiaNet ( www.asianetnews.net )--

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