EU Scientific Committee Recommends Approval of Cymbalta(R) For the Treatment of Diabetic Peripheral Neuropathic Pain

EU Scientific Committee Recommends Approval of Cymbalta(R) For
the Treatment of Diabetic Peripheral Neuropathic Pain
Committee Makes Recommendation After Reviewing Data Package Supporting the
Product's Safety and Efficacy Profile 


INDIANAPOLIS, Indiana, February 18  /PRNewswire-FirstCall/ -- The medical
advisory board of the European Medicines Agency (EMEA), which regulates
pharmaceuticals in Europe, has recommended the approval of duloxetine
hydrochloride (sold in the United States as Cymbalta) as safe and effective for
the management of diabetic peripheral neuropathic pain (DPNP) in adults, Eli
Lilly and Company announced today.

If, as expected, the European Commisssion accepts the recommendation of its
Committee for Medicinal Products for Human Use (CHMP), it would be the second
major approval of Cymbalta for the management of DPNP, following the September
2004 approval by the U.S. Food and Drug Administration. Also, the drug was
twice approved as safe and effective for other major medical conditions in
Europe - once under the name Yentreve(R), for the treatment of
moderate-to-severe stress urinary incontinence, and once as Cymbalta, for the
treatment of major depressive episodes[1]. Duloxetine is not approved in the
United States for the treatment of stress urinary incontinence.

"This regulatory opinion could soon pave the way for a new safe and effective
treatment in Europe for a very debilitating condition," said Dan Ziegler, M.D.,
German Diabetes Clinic of the German Diabetes Research Center, M.D. "Many
people with diabetic peripheral neuropathic pain are elderly, have multiple
health problems and are on multiple medications."

Although it does not change the underlying nerve damage caused by diabetic
peripheral neuropathy, Cymbalta does help relieve the burning, stabbing and
shooting pain that is the hallmark of this condition. In addition to its
once-a-day dosing schedule, Cymbalta is not a controlled substance, unlike some
other medications used to manage DPNP.

The CHMP, which comprises regulators from the 25 European Union countries,
based its positive opinion on its review of the comprehensive data package that
included, in part, data from two randomized, 12-week, double-blind,
placebo-controlled, fixed-dose studies of 60 and 120 mg per day, in 791
non-depressed adults who had the disorder for at least six months.

In both studies, duloxetine significantly reduced 24-hour average pain,
compared with placebo. Improvements were noted as early as the first week of
treatment and continued for the duration of the studies. In addition,
duloxetine showed rapid onset of action and effect in reducing pain caused by
diabetic neuropathy at both 60mg per day and 120mg per day, and was effective
in relieving pain at night[2]. Nighttime pain is especially troublesome to many
patients with diabetic neuropathy because it can interfere with sleep.

On average, patients in the studies were 60 years old, suffered from diabetes
for 11 years and related diabetic neuropathy for four years, and rated their
pain as moderate to moderately severe at the start of the trials.

Following the CHMP's positive opinion for duloxetine for diabetic peripheral
neuropathic pain, the European Commission is expected to grant marketing
authorization within the next few months.

About Cymbalta

Serotonin and norepinephrine are two neurotransmitters, or chemical messengers,
believed to help regulate a person's emotions and sensitivity to pain. Research
suggests that increasing levels of serotonin and norepinephrine in the brain
and spinal cord can reduce the body's sensation of pain from the nerve damage
caused by diabetes.

Based on preclinical data, Cymbalta (pronounced sim-BAWL'-tuh) is a balanced
and potent reuptake inhibitor of serotonin and norepinephrine[3]. It is
indicated in the United States for the treatment of major depression and the
management of diabetic peripheral neuropathic pain. The European Commission has
also approved duloxetine for the treatment of major depression and
moderate-to-severe stress urinary incontinence in adults. As duloxetine has not
been studied in children, Lilly discourages its use in those under 18.

Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax), a
medicine for bipolar depression also marketed by Lilly. Symbyax is a
combination of olanzapine, the active ingredient in Zyprexa(R), and fluoxetine,
the active ingredient in Prozac(R). Symbyax is available in capsules of 6 mg/25
mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg. Cymbalta
is available in 20 mg, 30 mg and 60 mg capsules.

Important Safety Information

In clinical studies, antidepressants increased the risk of suicidal thinking
and behavior in children and adolescents with depression and other psychiatric
disorders. Anyone considering the use of Cymbalta or any other antidepressant
in a child or adolescent must balance the risk with the clinical need. Patients
who are starting therapy should be observed closely. Families and caregivers
should discuss with the doctor any observations of worsening depression
symptoms, suicidal thinking and behavior, or unusual changes in behavior.
Cymbalta is not approved for use in patients under the age of 18.

Patients on antidepressants and their families or caregivers should watch for
worsening depression symptoms, unusual changes in behavior and thoughts of
suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping,
irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme
hyperactivity. Call the doctor if you have thoughts of suicide or if any of
these are severe or occur suddenly. Be especially observant at the beginning of
treatment or 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 have recently taken a type of antidepressant called a monoamine
oxidase inhibitor (MAOI), are taking thioridazine or have uncontrolled
narrow-angle glaucoma, you should not take Cymbalta. Talk with your doctor
before taking Cymbalta if you have liver or kidney problems, glaucoma or
consume large quantities of alcohol. Women who are pregnant should talk with
their doctor before taking Cymbalta. Breast feeding while taking Cymbalta is
not recommended.

In clinical studies of Cymbalta for depression, the most common side effects
were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness,
and increased sweating. Cymbalta also is approved for the management of
neuropathic pain associated with diabetic peripheral neuropathy. In clinical
studies of Cymbalta in these patients, the most common side effects were
nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating,
decreased appetite, and loss of strength or energy. In all clinical trials,
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 prescribing information, including Boxed Warming, visit
http://www.cymbalta.com/.

About Eli Lilly and Company

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
http://www.lilly.com/.

P-LLY

This press release contains forward-looking statements about the potential of
duloxetine for the treatment of diabetic neuropathic pain and reflects Lilly's
current beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of commercialization. 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 statements.

References

[1] In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a
long-term agreement to jointly develop and commercialize duloxetine
hydrochloride. This partnership covers most countries worldwide with few
exceptions. In the United States, the collaboration excludes neuroscience
indications. In the United States, Cymbalta for depression and diabetic
peripheral neuropathic pain are marketed by Lilly and Quintiles.

[2] Wernicke JF, Lu Y, D'Souza DN, Waninger A, Tran PV. Duloxetine at doses of
60 mg QD ad 60 mg BID is effective treatment of diabetic neuropathic pain.
Paper presented at: American Academy of Neurology; April 24-May 1, 2004; San
Francisco, CA.

[3] Bymaster F, Dreshfield-Ahmad L, Threlkeld P, Shaw J, Thompson B, Nelson D,
et al. Comparative affinity of duloxetine and venlafaxine for serotonin and
norepinephrine transporters in vitro and in vivo, human serotonin receptor
subtypes, and other neuronal receptors. Neuropsychopharmacology.
2001;25(6):871-880. 

DATASOURCE: Eli Lilly and Company and Boehringer Ingelheim GmbH



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