MEDIA RELEASE PR36091
/C O R R E C T I O N -- Eli Lilly and Company/
INDIANAPOLIS and INGELHEIM, Sept. 12 /PRNewswire-AsiaNet/ --
In the news release, New Data Show Patients With Chronic Low Back Pain Maintained
Pain Reduction on Duloxetine, issued 11-Sep-2009 by Eli Lilly and Company over PR
Newswire, the third paragraph, third sentence should read "A total of 18 patients in
the study discontinued due to adverse events during the extension phase." The phrase
"13 in the placebo-treated group and five in the duloxetine-treated group" at the end
of that sentence should be disregarded. The complete, corrected release follows:
New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on
Duloxetine
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.
"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
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
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:
(3) International Association for the Study of Pain. "IASP Pain Terminology"
pain.org/AM/Template.cfm?Section=General_Resource_Links&Template=/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:
2009.
SOURCE: Eli Lilly and Company
CONTACT: Sonja Popp-Stahly,
+1-317-655-2993,
spopp-stahly@lilly.com;
or John Pugh,
+ 49 (6132) 77-2964,
john.pugh@boehringer-ingelheim.com
(LLY)
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