New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on Duloxetine

Indianapolis and Ingelheim, Germany (ots/PRNewswire) -

- Further Pain Reduction on Duloxetine Shown During Study's
Extension Phase

New data show patients with chronic low back pain on duloxetine
hydrochloride (Cymbalta(R)) maintained reductions in pain for 41
weeks.(1) In patients who initially responded to duloxetine, this
maintenance of pain reduction was accompanied by further reduction in
pain that was statistically significant as measured by the Brief Pain
Inventory (BPI) average pain rating.(1) The data will be presented
today at the sixth triennial congress of the European Federation of
International Association for the Study of Pain Chapters (EFIC(R)).

A total of 181 patients enrolled in the open-label 41-week
extension phase of the study, designed to evaluate long-term
maintenance of effect in patients with chronic low back pain taking
duloxetine 60 mg or 120 mg once daily. Maintenance of effect was
assessed in the responders - 58 duloxetine patients who had
experienced at least 30 percent pain reduction from baseline during
the 13-week, placebo-controlled acute phase of the study.

The most common adverse events in the study (those occurring in
more than 5 percent of study participants) included headache, nausea,
upper abdominal pain, excessive sweating (hyperhidrosis), back pain,
diarrhoea and fatigue. Adverse events were similar to those seen in
previous duloxetine studies.(1) A total of 18 patients in the study
discontinued due to adverse events during the extension phase - 13 in
the placebo-treated group and five in the duloxetine-treated group.

"Chronic low back pain is a painful and debilitating condition
and this study is an important step in the fight against it," said
Vladimir Skljarevski, M.D., lead study author and a neurologist and
medical fellow at Lilly Research Laboratories.

Experts estimate chronic low back pain affects between 4 percent
and 33 percent of the world's population at any one time.(2)
According to the International Association for the Study of Pain
(IASP), the pain is an unpleasant sensory and emotional experience
associated with actual or potential tissue damage, or described in
terms of such damage.(3) Chronic pain is defined as pain that
persists beyond acute pain or beyond the expected time for an injury
to heal.(4) Men and women are equally affected by chronic low back
pain, and it occurs most often between the ages of 30 and 50.(5)

In Europe, duloxetine is approved for the treatment of diabetic
peripheral neuropathic pain (DPNP), major depressive disorder (MDD),
generalised anxiety disorder (GAD) and stress urinary incontinence
(SUI)

Duloxetine is approved in various countries outside of Europe for
the management of DPNP, for the treatment of MDD, for the treatment
of GAD and for the management of fibromyalgia.

Notes to Editors:

Methods

Patients (N=181) with chronic low back pain (defined as low back
pain present on most days for the preceding six months or longer)
entered the study's 41-week extension phase and received duloxetine
60 mg or 120 mg once daily after completing a 13-week,
placebo-controlled acute phase. Patients completing the acute phase
on duloxetine remained on the same dose while those on placebo were
switched to duloxetine. Maintenance of effect was assessed in 58
duloxetine patients who were responders [greater than or equal to 30
percent reduction in Brief Pain Inventory (BPI) average pain] at the
end of the acute phase. If the upper bound of the 97.5 percent
Confidence Interval (CI) of the mean change from the end of the acute
phase for the BPI average pain was less than the pre-specified margin
of 1.5, then maintenance of effect was established.

About Duloxetine

While duloxetine's mechanism of action in humans is not fully
known, it is believed to affect both serotonin and
norepinephrine/noradrenaline-mediated nerve signaling in the brain
and the spinal cord. Based on pre-clinical studies, duloxetine is a
reuptake inhibitor of serotonin and norepinephrine/noradrenaline.
Scientists believe its effect on mood and pain perception is due to
increasing the activity of serotonin and norepinephrine in the
central nervous system.

Duloxetine is approved for the treatment of major depressive
disorder and diabetic peripheral neuropathic pain in many countries
and is also approved in some countries for the treatment of stress
urinary incontinence and generalized anxiety disorder and the
management of fibromyalgia. Duloxetine is approved only for adults 18
and over. There is a possibility of an increased risk of suicidal
thoughts or behavior in children and young adults treated with
antidepressants. Patients should call their doctor right away if they
experience worsening depression symptoms, unusual changes in behavior
or thoughts of suicide, especially at the beginning of treatment or
after a change in dose.

Patients taking duloxetine may experience dizziness or fainting
upon standing. The most common side effects of duloxetine include:

- For depression: Nausea, dry mouth, headache, insomnia,
diarrhoea.
- For diabetic peripheral neuropathic pain: Nausea, somnolence
(sleepiness), fatigue, headache, dizziness.
- For generalized anxiety disorder: Nausea, fatigue, dry mouth,
drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis
(excessive perspiration), decreased libido, vomiting, ejaculation delay
and erectile dysfunction.
- For stress urinary incontinence: Nausea, dry mouth, fatigue.
- For fibromyalgia: Constipation, dry mouth, nausea, diarrhoea,
fatigue, decreased appetite, dizziness, headache, somnolence
(sleepiness), insomnia.

This is not a complete list of side effects.

Duloxetine is contraindicated in patients who are allergic to it,
who have liver disease resulting in hepatic impairment, who are
taking a monoamine oxidase inhibitor (MAOI), fluvoxamine,
ciprofloxacin or enoxacine or who have severe kidney disease. The
initiation of treatment with duloxetine also is contraindicated in
patients with uncontrolled hypertension that could expose patients to
a potential risk of hypertensive crisis.

Eli Lilly and Company and Boehringer Ingelheim

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 neuroscience
indications in most countries outside of the United States and Japan,
with few exceptions.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of 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. For more
information please visit www.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 135 affiliates in 47 countries and almost
38,900 employees. Since it was founded in 1885, the family-owned
company has been committed to researching, developing, manufacturing
and marketing novel products of high therapeutic value for human and
veterinary medicine. In 2007, Boehringer Ingelheim posted net sales
of 10.9 billion euro while spending one fifth of net sales in its
largest business segment Prescription Medicines on research and
development. For more information please visit
www.boehringer-ingelheim.com.

Duloxetine for major depressive episodes, diabetic peripheral
neuropathic pain and generalized anxiety disorder is marketed by
Lilly and Boehringer Ingelheim in all countries included in the
partnership under the brand name Cymbalta(R), except for Greece,
Italy and Spain. In Greece, Italy and Spain Lilly markets the product
as Cymbalta(R) and Boehringer Ingelheim markets the product as
Xeristar(R). In addition, in Germany, Lilly and Boehringer Ingelheim
market duloxetine for diabetic peripheral neuropathic pain as
Ariclaim(R). In the United States, Cymbalta(R) is marketed by Lilly
and Quintiles. In Japan, duloxetine is co-developed and co-marketed
by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly
under the brand name Yentreve(R).

This press release contains forward-looking statements about the
potential of Cymbalta for chronic pain including the management of
chronic low back pain 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 continue 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 statements.

References

(1) Skljarevski V. et al. "Maintenance of Effect of Duloxetine in
Patients with Chronic Low Back Pain." Poster presented at European
Federation of Chapters of the International Association for the Study
of Pain, September 2009.

(2) World Health Organization. Chronic rheumatic conditions.
Available at: http://www.who.int/chp/topics/rheumatic/en. Accessed on
26 May 2009.

(3) International Association for the Study of Pain. "IASP Pain
Terminology" Available at: http://www.iasp-pain.org/AM/Template.cfm?S
ection=General_Resource_Links&Templ
ate=/CM/HTMLDisplay.cfm&ContentID=3058#Pain. Accessed on 26 May 2009.

(4) American Pain Society. "Pain Control in the Primary Care
Setting." 2006:15.

(5) National Institute of Neurological Disorders and Stroke. "Low
Back Pain Fact Sheet." Available at:
http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm.
Accessed on 26 May 2009.

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ots Originaltext: Eli Lilly and Company
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Contact:
Sonja Popp-Stahly, +1-317-655-2993, spopp-stahly@lilly.com; or John
Pugh, + 49-(6132)-77-2964, john.pugh@boehringer-ingelheim.com, Logo:
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