INDIANAPOLIS and INGELHEIM--11 Sep--PRNewswire-AsiaNet/InfoQuest
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
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)
"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
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)
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
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
- 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
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
References
(1) Skljarevski V. et al. "Maintenance of Effect of Duloxetine in
(2) World Health Organization. Chronic rheumatic conditions. Available
(3) International Association for the Study of Pain. "IASP Pain
(4) American Pain Society. "Pain Control in the Primary Care Setting."
(5) National Institute of Neurological Disorders and Stroke. "Low Back
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SOURCE: Eli Lilly and Company
CONTACT: Sonja Popp-Stahly,
+1-317-655-2993,
or John Pugh,
+ 49 (6132) 77-2964,
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