TORONTO, April 29 /CNW/ - Eli Lilly Canada announced today that Health
Canada has approved Cymbalta® (duloxetine HCl) for the management of chronic low back pain (CLBP).
The recommended dose is 60 mg once daily.
The approval is based on the results of two randomized, double-blind,
12-13 week, placebo-controlled studies in 637 adult patients with a
clinical diagnosis of CLBP with pain present on most days for at least
6 months and no sign of radiculopathy or spinal stenosis.1 The primary efficacy endpoint in both studies was a reduction in pain
severity as measured by the Brief Pain Inventory (PBI) 24-hour average
pain rating on the 11-point Likert scale (0 = no pain; 10 = worst
possible pain). In both studies, patients taking Cymbalta 60 mg once
daily experienced significantly greater pain reduction compared to
placebo. In addition, some patients reported pain reduction as early as one week
into the trial after starting the 60 mg dose, which continued
throughout the study.
Cymbalta has been evaluated for safety in 698 patients with CLBP. The
most common side effects reported in the two studies included nausea,
insomnia, somnolence, constipation, dry mouth, fatigue and dizziness.1
About Low Back Pain2
Most adults experience low back pain at some point in their lives. Men
and women are equally affected. Low back pain occurs most often between
ages 30 and 50, due in part to the aging process but also as a result
of sedentary life styles with too little (sometimes punctuated by too
much) exercise. Fortunately, most occurrences go away within a few
days. Others take much longer to resolve or lead to more serious
conditions.
What Causes CLBP?2
Chronic back pain is measured by duration — pain that persists for more
than three months is considered chronic. It is often progressive and
the cause can be difficult to determine. Low back pain may reflect
nerve or muscle irritation or bone lesions. Most low back pain follows
injury or trauma to the back, but pain may also be caused by
degenerative conditions such as arthritis or disc disease, osteoporosis
or other bone diseases, or rarely by infections, tumours, or congenital
abnormalities in the spine.
About Cymbalta
Cymbalta is a potent and balanced serotonin and norepinephrine reuptake
inhibitor (SNRI), which targets two chemical messengers in the brain
believed to play a role in sensitivity to pain - serotonin and
norepinephrine. While the mechanism of action of duloxetine in humans
is not fully known, scientists believe its effect on pain perception is
due to increasing the activity of serotonin and norepinephrine in the
central nervous system.
Cymbalta is now indicated in Canada for three distinct pain conditions:
CLBP, neuropathic pain associated with diabetic peripheral neuropathy
and fibromyalgia. It is also indicated in Canada for the symptomatic
relief of major depressive disorder (MDD) and generalized anxiety
disorder (GAD).
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) including linezolid and methylene
blue, thiorazidine, potent CYP1A2 inhibitors (e.g. fluvoxamine), and
some guinolone antibiotics (e.g. ciprofloxacin or enoxacine), who have
uncontrolled narrow glaucoma, or who have severe kidney disease.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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, Indiana, Lilly provides answers -
through medicines and information - for some of the world's most urgent
medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario,
employs close to 500 people across the country. Additional information
about Eli Lilly Canada can be found at www.lilly.ca.
® Registered trademark owned by Eli Lilly and Company; used under
license.
References:
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1 Cymbalta product monograph. Eli Lilly Canada. 2011.
2 National Institutes of Health. Low Back Fain Fact Sheet. Available
at: http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm Last updated February 18, 2011. Accessed April 14, 2011.
