Cymbalta(R) Helped Patients with Depression Stay Better Longer, New Data Show

Cymbalta(R) Helped Patients with Depression Stay Better Longer,
New Data Show
Rescue dosing strategy was safe and effective in relapse prevention study 


NEW YORK, May 3  /PRNewswire-FirstCall/ -- Patients treated successfully with
60 mg per day of the investigational antidepressant Cymbalta(R) (duloxetine
hydrochloride), were less likely to have their emotional and physical symptoms
of depression return than those who stopped taking medication after beginning
to feel better, according to results of a 38-week study presented today at the
American Psychiatric Association meeting.

At the conclusion of the trial, roughly 80 percent of Cymbalta-treated patients
remained free of the emotional and physical symptoms of depression. Increasing
the dose of Cymbalta from 60 mg once a day to 120 mg (60 mg twice daily) was a
benefit for the majority of the smaller group of patients whose symptoms did
return (n=29), and did not produce additional side effects. Increasing daily
doses of medication is a common clinical practice when patients experience a
re-emergence of symptoms.

In clinical practice for the treatment of major depressive disorder, the
prevention of relapse and the ability to "rescue" relapsed patients with a
previously well-tolerated and efficacious antidepressant is a significant
advantage.  In this study, the time to relapse was longer in Cymbalta-treated
patients than in those who received sugar pills.

"Patients have the best chance of sustaining symptom control when they continue
treatment for at least six months after their symptoms resolve," said Michael
Detke, M.D., Ph.D., Cymbalta medical director, Eli Lilly and Company. "This
study demonstrates that in these patients Cymbalta was effective at keeping
depression at bay.  These data can also give healthcare practitioners insight
into a compound's safety when increasing the dose in instances when relapse
does occur."

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.  The U.S.
Food and Drug Administration is reviewing it as a potential treatment for Major
Depressive Disorder.

Additional Study Highlights

*  By 12 weeks, 68 percent of patients treated with 60 mg of Cymbalta once
daily responded to treatment, defined as 50 percent reduction in symptoms, and
53 percent were virtually symptom free, which is the definition of achieving
remission.

*  By 38 weeks, patients treated with Cymbalta had overall greater symptom
control (HAMD17) compared with patients taking sugar pills.

*  Cymbalta-treated patients had greater relief of physical symptoms, including
headaches, back pain, shoulder pain, and pain while awake and reported
increased quality of life (QLDS), by the end of the study.  Among patients who
relapsed while taking 60 mg of Cymbalta once a day, 62 percent responded to an
increased dose, with 38 percent becoming virtually symptom free.

*  Among patients whose symptoms returned while taking a sugar pill, 77 percent
responded once they resumed taking 60 mg Cymbalta once a day with 57 percent
becoming virtually symptom free.

  *  Cymbalta 60 mg, at both once and twice daily, was well tolerated.

  Methods


Data were gathered from 533 adult outpatients who participated in a randomized,
double-blind, multi-site, placebo-controlled study in Europe and the United
States.  Participants met the criteria for major depressive disorder and had
Hamilton Depression Rating Scale (HAMD17) scores of >/= 18 at the first and
second visits and a Clinical Global Impression-Severity (CGI- Severity) score
of >/= 4 at the first and second visits.

During the first 12 weeks of the study, all patients (n=533) received 60 mg of
Cymbalta in an open-label setting.  At the beginning of the continuation phase
(weeks 13-38), patients who no longer met the criteria for major depressive
disorder were randomized to either continue on 60 mg of Cymbalta (n=136) or
receive placebo (n=142).  Patients who relapsed during this period had the
option of entering the rescue phase for up to 12 weeks. During this phase,
placebo-treated patients received 60 mg of Cymbalta (n=56) and Cymbalta-treated
patients had their dose doubled to 120 mg/day (n=29). All patients (n=200)
entered a one-week follow-up phase after either completing the study or
following early discontinuation during either the continuation or rescue
phases.  At that time, Cymbalta-treated patients had their dose reduced by 50
percent for three days and safety and efficacy data was collected.

The primary efficacy measure was analysis of time to relapse.  Secondary
efficacy measures analyzed were HAMD17 subscores, the CGI Severity scale, the
Patient Global Impression of Improvement (PGI-I) scale, the Symptom
Questionnaire-Somatic subscale (SQ-SS), Visual analog scales (VAS), the Quality
of Life in Depression Scale (QLDS) and the Sheehan Disability Scale (SDS).

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 based upon eight- and nine-week
trials.  Duloxetine hydrochloride also is being studied by Lilly for the
treatment of stress urinary incontinence and diabetic neuropathic pain,
conditions 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

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DATASOURCE: Eli Lilly and Company



CONTACT:  David Shaffer (US), [phone], cell: [phone];

Jennifer Yoder (OUS), [phone], cell: [phone], both of Eli

Lilly and Company

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