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

     
BW20021029000375  20021029T140010Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Cymbalta Data Suggest Rapid and Sustained
Response by First Week of Therapy

    Business Editors
    UK REGULATORY NEWS

    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.                       

   Short Name: (ELI) & Co
   Category Code: MSC
   Sequence Number: 00001079
   Time of Receipt (offset from UTC): 20021029T111410+0000

    --30--slb/cl* mh/uk

    CONTACT: Eli Lilly and Company      
             Anne Griffin, 317/276-3254
             
    KEYWORD:  INDIANA UNITED KINGDOM INTERNATIONAL EUROPE    
    INDUSTRY KEYWORD:  MEDICAL PHARMACEUTICAL            
    SOURCE:  Eli Lilly and Company                     

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