Study Showed New Episodes of Depression Delayed in People Taking Duloxetine (y 2)

Duloxetine is approved for the treatment of major depressive disorder and diabetic peripheral neuropathic pain in many countries and is also approved in some countries for the treatment of stress urinary incontinence 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 behavior in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behavior 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 generalized anxiety disorder: Nausea, fatigue, dry mouth,
       drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis
       (excessive perspiration), decreased libido, vomiting, ejaculation
       delay and erectile dysfunction.
    -- For stress urinary incontinence: Nausea, dry mouth, fatigue

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 patients 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. For more information please visit 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.com.

Duloxetine for major depressive episodes, diabetic peripheral neuropathic pain and generalized anxiety disorder is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta(R), except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly markets the product as Cymbalta(R) and Boehringer Ingelheim markets the product as Xeristar(R). In addition, in Germany, Lilly and Boehringer Ingelheim market duloxetine for diabetic peripheral neuropathic pain as Ariclaim(R). In the United States, Cymbalta(R) is marketed by Lilly and Quintiles. In Japan, duloxetine is 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).

P--LLY

References

(1) Mueller TI, Leon AC, Keller MB, et al. Recurrence after recovery from major depressive disorder during 15 years of observational follow-up." Am J Psychiatry 1999;156:1000-1006.

(2) First Ml B. et al. DSM-IV-TR(R) Handbook of Differential Diagnosis. American Psychiatric Publishing, Inc. 2002; 1-6

(3) Kessing LV. Recurrence in affective disorder: II. Effect of age and gender. Br J Psychiatry 1998;172:29-34.

(4) Solomon DA, Keller MB, Leon AC, et al. Multiple recurrences of major depressive disorder. Am J Psychiatry 2000;157:229-233

(5) Melartin TK, Rytsala HJ, Leskela US, et al. Severity and comorbidity predict episode duration and recurrence of DSM-IV major depressive disorder. J Clin Psychiatry 2004;65:810-819.

(6) Judd LL, Akiskal HS, Maser JD, et al. Major depressive disorder: a prospective study of residual subthreshold depressive symptoms as predictor of rapid relapse. J Affect Disord 1998;50:97-108

(7) Maletic, V., et al. Neurobiology of depression: an integrated view of key findings. Int J Clin Pract 2007 Dec; 61(12):2030-40.

(8) World Health Organization. Factsheet - Depression, 2008. WHO. Available at: http://www.who.int/mental_health/managem.... Accessed on 21 November 2008

(9) American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.

(10) Paykel ES, Scott J, Teasdale JD, et al. Prevention of relapse in residual depression an important outcome in depression. Psychol Med. 1995;25:1171- 1180.

    
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Charles McAtee, Eli Lilly and Company, +1-317-271-1566; or John Pugh, Boehringer Ingelheim, +49-(6132)-77-2964. Photo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO, http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO