MEDIA RELEASE PR36075
New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on
Duloxetine
INDIANAPOLIS and INGELHEIM, Sept. 11 /PRNewswire-AsiaNet/ --
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
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
(3) International Association for the Study of Pain. "IASP Pain
Terminology" Available at:
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:
26 May 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
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