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FDA Approves Lilly's Cymbalta(R) for the Treatment of Depression

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Eli Lilly and Company logo. (PRNewsFoto)[AG]
      Dual-reuptake inhibitor judged safe and effective, giving doctors
             and patients a new option for treating the emotional
                 and painful physical symptoms of depression

    INDIANAPOLIS, Aug. 4 /PRNewswire-FirstCall/ -- The U.S. Food and Drug
Administration has approved Cymbalta(R) (duloxetine HCl; pronounced
SIM-BALL-TA), judging it a safe and effective treatment for major depressive
disorder, Eli Lilly and Company (NYSE: LLY) announced today.
    Cymbalta, a balanced and potent reuptake inhibitor of serotonin and
norepinephrine, has been studied in more than 6,000 adults with major
depression worldwide.  Its approval gives healthcare professionals and
patients a long-awaited new option for treating the broad range of emotional
and physical symptoms of depression.  Today, only 25-35 percent of patients
treated for depression in clinical studies experience relief from all of their
disease symptoms.(1)
    "Depression is a whole-body illness, but most modern antidepressants treat
the emotional symptoms, such as crying and sadness, better than they treat the
physical symptoms of depression," said Dr. Stephen Stahl, chairman of the
Neuroscience Education Institute and adjunct professor of psychiatry at the
University of California at San Diego School of Medicine.  "Because of its
dual action on serotonin and norepinephrine, Cymbalta offers physicians a new
opportunity to help patients with depression, particularly those who
experience the common physical symptoms of the disease, such as vague aches
and pains."
    Neurotransmitters are believed to help regulate a person's emotions and
sensitivity to pain.  Scientists believe that if these neurotransmitters are
out of balance, a person may become depressed and be more likely to feel
painful physical symptoms.  The combination of emotional and painful physical
effects of depression can have a tremendous negative impact on a person's
quality of life.(2)
    "Lilly's leadership in neuroscience and dedication to the treatment of
depression is well established," said Sidney Taurel, Lilly's chairman,
president and chief executive officer.  "Lilly is committed to solving the
world's most pressing neuroscience problems, through research programs in
Alzheimer's and Parkinson's as well as through our established expertise in
depression, schizophrenia, bipolar disorder and Attention-
Deficit/Hyperactivity Disorder."
    Lilly demonstrated Cymbalta's effectiveness in treating major depression
with data from four placebo-controlled clinical studies, all in adults.  The
safety and efficacy of Cymbalta in children have not been studied.
    Milt Meyers, a participant in a Cymbalta clinical trial, found it worked
for him.  "Cymbalta worked for me," Meyers said.  "I felt really good for the
first time in a long time.  I really felt like I was on the right track."
    Cymbalta comes in a capsule and can be taken once a day.  In clinical
trials, Cymbalta was studied in a dose range of 40-120 mg per day.  The
recommended daily dose is 60 mg.
    Duloxetine hydrochloride also is being studied for the treatment of stress
urinary incontinence and diabetic neuropathic pain, conditions believed to
respond to treatment with both serotonin and norepinephrine.

    About Depression
    Nearly 19 million Americans suffer from depression each year, making it
one of the leading causes of disability according to the World Health
Organization.  Current medical literature suggests that patients who are
successfully treated for all their depressive symptoms, including both the
emotional and painful physical ones, may be more likely to achieve remission
than those whose physical symptoms are not alleviated.(1),(3),(4),(5)

    Patient Experience
    In clinical trials, Cymbalta was safe and effective.  Not all patients
respond the same.  The experience of the patient quoted in this release might
not be typical.

    Important Safety Information
    Depression, as a disease, can be associated with periods when the symptoms
can worsen or thoughts of suicide can emerge.  Patients and their families
should watch for these as well as for anxiety, agitation, panic, difficulty
sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness,
or overexcitement and hyperactivity.  Call the doctor if any of these are
severe or occur suddenly.  Be especially observant at the initiation of
antidepressant drug therapy and whenever there is a change in dose.
    Prescription Cymbalta is not for everyone.  People who are allergic to
duloxetine hydrochloride or the other ingredients in Cymbalta should not take
it.  If you are taking thioridazine or if you are taking or have recently
taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI),
you should not take Cymbalta.  It also should not be administered to patients
with any hepatic insufficiency, end-stage renal disease or uncontrolled,
narrow-angle glaucoma.  Cymbalta ordinarily should not be prescribed to
patients with substantial alcohol use.  Women who are pregnant should talk
with their doctor before taking Cymbalta.  Nursing while taking Cymbalta is
not recommended.
    In clinical studies, the most common side effects were nausea, dry mouth,
constipation, decreased appetite, fatigue, sleepiness and increased sweating.
Most people were not bothered enough by side effects to stop taking Cymbalta.
Your doctor may periodically check your blood pressure.  Don't stop taking
Cymbalta without talking to your doctor.
    For full patient information, visit .

    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 .
    This press release contains forward-looking statements about the potential
of Cymbalta for the treatment of major depressive disorder and reflects
Lilly's current beliefs.  However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of development and
commercialization.  There is no guarantee that the product will prove to be
commercially successful.  For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States Securities and
Exchange Commission.  Lilly undertakes no duty to update forward-looking
    (1)  Tran PV, Bymaster FP, McNamara RK, et al. Dual Monoamine Modulation
for Improved Treatment of Major Depressive Disorder, J Clin
Psychopharmacology, 2003; 23: 78-86
    (2)  The Regents of the University of Michigan. Beyond Sadness. Bridging
the gap between emotional and physical symptoms of depression. Ann Arbor, MI,
    (3)  Nemeroff CB et al.  Duloxetine for the Treatment of Major Depressive
Disorder. Psychoharmacol Bul. 2002; 36 (4):106-132.
    (4)  Ohayon, M., et al.  Using Chronic Pain to Predict Depressive
Morbidity in the General Population.  Arch Gen Psychiatry 2003; 60: 39-47.
    (5)  Poster presented at American Psychiatric Association annual meeting.
May 19, 2003. San Francisco, CA.

    (Logo: )

SOURCE Eli Lilly and Company
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