Cymbalta(R) Helped Patients with Depression Feel Better Fast, According to Pooled Data from Two 9-week Trials NEW YORK, May 5 /PRNewswire-FirstCall/ -- Patients treated with 60 mg per day of the investigational antidepressant Cymbalta(R) (duloxetine hydrochloride), experienced significant improvements in both mood and painful physical symptoms after one week, according to pooled data from two 9-week studies presented at the American Psychiatric Association meeting. The data show that response to Cymbalta was fastest for the core emotional and painful physical symptoms of depression. After the first week of treatment, significant improvements were observed in depressed mood, feelings of guilt, suicidal ideation, work and activities, anxiety, back pain and shoulder pain. "Patients are more likely to stay on a medication if they feel symptom relief early on in the course of treatment," said Robert Hirschfeld, M.D., Titus Harris Chair and Professor and Chair of Psychiatry and Behavioral Sciences at the University of Texas Medical Branch in Galveston. "These data demonstrate that in these patients duloxetine was effective at providing improvements in several symptoms of depression as early as one week." Complete elimination of symptoms, or remission, is the primary goal of depression treatment. Treating the full spectrum of emotional and physical symptoms to remission puts patients at a decreased risk of relapse.(1, 2) Among the 19 million Americans with depression annually, an estimated 50 percent will suffer a relapse within two years.(3) Cymbalta, is a potent serotonin and norepinephrine reuptake inhibitor. It is being reviewed by the U.S. Food and Drug Administration as a potential treatment for Major Depressive Disorder. Additional Study Highlights * At week one, patients treated with Cymbalta experienced greater improvement in core emotional (depressed mood, guilt, suicidal ideation, work/activities, psychic anxiety) and physical symptoms (back and shoulder pain) of depression compared with patients treated with sugar pills. * In patients treated with Cymbalta, greater improvements in sleep, genital and non-painful somatic symptoms were achieved between five and nine weeks. * At weeks one and two, patients treated with sugar pills experienced greater improvement in somatic gastrointestinal (GI) symptoms and weight loss than patients taking Cymbalta; by week nine, however, Cymbalta-treated patients experienced significant improvements in somatic GI symptoms in comparison with patients taking sugar pills. Methods Data were pooled from two identical, randomized, double-blind, parallel- group, placebo-controlled studies. Participants were males and females, 18 years of age and older, who met DSM-IV criteria for major depressive disorder, had Hamilton Depression Rating Scale (HAMD17) scores of >/= 15 and Clinical Global Impression-Severity (CGI-S) scores of >/= 4 at baseline. Patients were not pre-screened for pain. Patients were randomized to receive 60 mg once daily of Cymbalta (n=244) or placebo (n=251) for up to 9 weeks. Mean changes in individual HAMD17 items and a visual analog scale (VAS) for pain (overall, shoulder and back) were analyzed. About Cymbalta In placebo-controlled clinical trials for Major Depressive Disorder, the most commonly observed adverse events (>/= 5 percent and at least twice placebo) for Cymbalta vs. placebo (n = 1,139 vs. 777) were: nausea (20 percent vs. 7 percent), dry mouth (15 percent vs. 6 percent), constipation (11 percent vs. 4 percent), decreased appetite (8 percent vs. 2 percent), fatigue (8 percent vs. 4 percent), sleepiness (7 percent vs. 3 percent), and increased sweating (6 percent vs. 2 percent). The overall discontinuation rate due to adverse events for Cymbalta vs. placebo was 10 percent vs. 4 percent. Nausea was the only common adverse event reported as a reason for discontinuation and considered to be drug related (1.4 percent vs. 0.1 percent). The US Food and Drug Administration issued an approvable letter for Cymbalta (duloxetine for depression) in September 2003. Duloxetine hydrochloride also is being studied by Lilly for the treatment of stress urinary incontinence and diabetic neuropathic pain. All three conditions are believed to be mediated by serotonin and norepinephrine. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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 http://www.lilly.com/ . This press release contains forward-looking statements about the potential of an investigational compound, duloxetine, for the treatment of depression and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indications(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no update to forward-looking statements. 1. Nierenberg, A. Long-Term Management of Chronic Depression. J Clin Psychiatry 2001; 62 (Suppl 6): 17-20 2. Delgado, P. Approaches to the Enhancement of Patient Adherence to Antidepressant Medication Treatment. J Clin Psychiatry 2000; 61 (Suppl 6): 6-9 3. Hirschfeld RMA, Keller MB, Panico S, et. al. The National Depressive and Manic Depressive Association Consensus Statement on the Undertreatment of Depression. JAMA, 1997; 277; 333-340 (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE: Eli Lilly and Company CONTACT: David Shaffer (US), +1-317-651-3710, cell: +1-317-997-0632, or Jennifer Yoder (OUS), +1-317-433-3445, cell: +1-317-652-0912, both of Eli Lilly and Company

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