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Cymbalta Data Suggest Rapid and Sustained Response by First Week of Therapy

Cymbalta Data Suggest Rapid and Sustained Response by First Week of Therapy

Business Editors, Health & Medical Writers

INDIANAPOLIS–(BUSINESS WIRE)–Oct. 29, 2002

Data presented showed that depressed patients taking Cymbalta(TM) 60mg once a day had significantly greater improvement in mood and anxiety measures than did placebo treated patients by the end of the first week of therapy. This same data indicated that the improvements seen by week one were also sustained throughout the studies. Other findings presented from an open label trial showed that 79 percent of patients achieved response and 69 percent of patients achieved remission of their symptoms after a year of therapy with either 80 mg/day or 120 mg/day of Cymbalta. Additionally, data from the one-year trial indicated Cymbalta to be relatively well tolerated and safe over long-term treatment. The data were shared at the 15th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas.

The pooled analysis of Cymbalta 60mg once daily showed:

— By week 1, Cymbalta-treated patients demonstrated a significant improvement in a measure of mood, as measured by Item 1 (Depressed Mood) of the Hamilton Depression Rating Scale, HAMD-17.

— Cymbalta-treated patients demonstrated a significantly greater improvement in their overall depressive symptoms by week 2, as measured by the HAMD-17 depression rating scale.

— By week 1, significantly more Cymbalta-treated patients demonstrated an improvement in a measure of anxiety associated with depression, as measured by Item 10 (Psychic Anxiety) of the HAMD-17.

— Cymbalta-treated patients demonstrated a significantly greater improvement in their anxiety associated with depression by week 2, as measured by the HAMD-17 Anxiety Sub-Scale.

— By the first week, physicians noted significantly more patients treated with Cymbalta showed improvement of depressive symptoms as measured by the Clinical Global Impression Scale of Severity (CGI-S Scale).

— As early as the first week, significantly more Cymbalta treated patients reported an improvement in their depression as measured by the Patient Global Impression of Improvement Scale (PGI-I Scale).

A rapid and sustained improvement in depressive symptoms may lead to an earlier restoration of functional well being and a potentially more cost effective outcome for the patient and healthcare provider.(1)

“Rapid response to treatment helps doctors recognize that a therapy may be the right one for the patient, but even more importantly if the patient is able to feel improvement quickly, the more likely that patient will stick with treatment and ultimately get well,” said Stephen K. Brannan, MD, Lilly research physician, who presented at the Congress.

Many experts believe treating the complete spectrum of depression symptoms is intrinsic to a lasting recovery. As well, combined action through two key neurotransmitters – serotonin and norepinephrine – may provide a more rapid and sustained clinical effect. Cymbalta is a dual reuptake inhibitor of both serotonin and norepinephrine, the two important neurotransmitters involved in depression.

Data from the one-year open label study revealed:

— Discontinuation due to adverse events was relatively low (17

percent over the course of the 52 weeks). Most adverse events

occurred early in the study period and were mild to moderate.

The only adverse events that occurred at a rate higher than 1

percent and led to discontinuation were nausea (1.5%) and

somnolence (1.4%).

— The rates of discontinuation resulting from a sexual adverse

event were erectile dysfunction (0.2%) and abnormal orgasm

(0.2%). After 52 weeks of treatment the mean change in weight

from baseline was an increase of 1.1kg.

— Adverse events that occurred at a rate of 3 percent or greater

upon abrupt discontinuation at the end of the study were

dizziness (8.3%), anxiety (4.3%) and nausea (4.2%).

Cymbalta approval pending

The FDA granted Eli Lilly and Company (NYSE:LLY) conditional approval for Cymbalta in September. Final approval is contingent upon labeling discussions and resolution of the company’s outstanding manufacturing issues. The duloxetine compound is also being studied by Lilly for treatment of stress urinary incontinence, a condition also mediated by serotonin and norepinephrine.

Methods

Results were obtained from a pooled analysis of two nine-week, double-blind, placebo-controlled studies in patients who met the criteria for MDD. A total of 512 patients were randomly assigned to receive either placebo (n=261) or Cymbalta 60 mg (n=251). Results were evaluated using the Hamilton Depression Rating Scale 17 as well as CGI-S and PGI-I scales.

Additional results were obtained from an open label, 52-week, multinational clinical trial involving 1,279 patients who met the criteria for major depressive disorder (MDD). Patients received Cymbalta 80 mg/day or 120 mg/day. Efficacy was measured on the CGI-Severity scale and with the HAMD-17 total, and PGI-Improvement depression scales.

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.com.

(1) Culpepper L. Early onset of antidepressant action: impact on

primary care. J Clin Psychiatry 2001;62 Suppl 4:4-6.

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