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Duloxetine NDA To Be Submitted in 2006

INDIANAPOLIS, Dec. 9 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:LLY) plans to submit a supplemental New Drug Application (sNDA) in 2006 to the Food and Drug Administration for Cymbalta(R) (duloxetine hydrochloride) for the treatment of generalized anxiety disorder (GAD). Lilly has completed two clinical trials, which the company believes will support this submission.

"People with generalized anxiety disorder experience a wide array of symptoms from excessive worry to difficulty concentrating. In addition, it is also common for patients to experience physical symptoms like muscle tension, restlessness or fatigue," explains Michael Detke, M.D., Ph.D., Cymbalta medical director, Eli Lilly and Company.

Every year four million Americans are diagnosed with generalized anxiety disorder, the majority of them women.(i) Unfortunately, it is common for people with generalized anxiety disorder to also experience other physical and mental disorders, including depression, eating disorders or substance abuse.(ii) Because generalized anxiety disorder presents with a variety of symptoms and is often a comorbid illness, it can be difficult to diagnose.(iii) When left untreated, symptoms may get progressively worse, significantly diminishing a patient's quality of life.(iv,v)

Patients with generalized anxiety disorder experience symptoms like exaggerated worry or chronic anxiety and irritability, which can lead to poor concentration, and procrastination.(vii) Generalized anxiety disorder may also include physical symptoms like muscle tension, restlessness and insomnia. Symptoms usually occur gradually and persist for at least six months, although episodes of generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.(vi,vii)

Cymbalta was approved for the treatment of major depression in August 2004, followed by another approval for the management of diabetic peripheral neuropathic pain, also known as diabetic nerve pain, in September 2004.

About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core depression symptoms and help regulate the perception of pain. Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms of depression. Based on pre- clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine. While the mechanism of action of duloxetine is not fully known, scientists believe its effect on both emotional symptoms and pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Cymbalta is not approved for use in pediatric patients.

Important Safety Information
In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child or adolescent must balance the risk with the clinical need. Patients who are starting therapy should be observed closely for worsening depression symptoms, suicidal thoughts or behavior, or unusual changes in behavior. Cymbalta is not approved for use in patients under the age of 18.

Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call the doctor if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant at the beginning of antidepressive treatment or whenever there is a change in dose.

Prescription Cymbalta is not for everyone. People who are allergic to Cymbalta or the other ingredients in Cymbalta should not take it. If you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have uncontrolled narrow- angle glaucoma, you should not take Cymbalta. Talk with your doctor before taking Cymbalta if you have liver or kidney problems, glaucoma or consume large quantities of alcohol. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended. Tell your doctor if you are taking other prescription or nonprescription medications.

In clinical studies of Cymbalta for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. Nausea was the most common side effect. For most people, the nausea was mild to moderate, and usually subsided within one-to-two weeks. Cymbalta is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy. In clinical studies of Cymbalta in these patients, the most common side effects were nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating, decreased appetite, and loss of strength or energy. In all clinical trials, most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor.

For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/.

(i) National Institute of Mental Health, "Anxiety Disorders." Available at http://www.nimh.nih.gov/publicat/anxiety.cfm. Accessed on December 5, 2005.
(ii) National Mental Health Association. "Anxiety Disorders." Available at: http://www.nmha.org/pbedu/anxiety/anxdis.cfm. Accessed on: November 28, 2005.
(iii) Gliatto, Michal, F. "Generalized Anxiety Disorder." American Family Physicians, Vol. 62/No. 7, October 1, 2000.
(iv) National Mental Health Association. "Anxiety Disorders." Available at: http://www.nmha.org/pbedu/anxiety/anxdis.cfm. Accessed on: November 28, 2005.
(v) National Institute of Mental Health. "Anxiety Disorders." Available at: http://www.nimh.nih.gov/publicat/anxiety.cfm. Accessed on: November 28, 2005.
(vi) Gliatto, Michal, F. "Generalized Anxiety Disorder." American Family Physicians, Vol. 62/No. 7, October 1, 2000.
(vii) APA. "Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition." 1994, pp 472-476.

Source: Eli Lilly and Company

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