Health Canada approves Cymbalta for the management of osteoarthritis knee pain

Health Canada approves Cymbalta for the management of osteoarthritis knee pain 
Once daily treatment a unique new option 
TORONTO, Nov. 7, 2012 /CNW/ - Eli Lilly Canada announced that Health Canada 
has approved Cymbalta(®) (duloxetine hydrochloride) for the management of 
chronic pain associated with osteoarthritis (OA) of the knee, representing a 
new analgesic treatment option for patients suffering from the condition. 
Cymbalta is the only serotonin and norepinephrine reuptake inhibitor (SNRI) 
approved in Canada for the management of chronic pain associated with OA of 
the knee. Other Cymbalta indications include: major depressive disorder, 
generalized anxiety disorder, neuropathic pain associated with diabetic 
peripheral neuropathy, pain associated with fibromyalgia and chronic low back 
"People with OA of the knee often experience debilitating pain and struggle to 
find an effective treatment without the safety or addiction concerns of other 
pain medications," said Dr. Philip Baer, Chair of the Section on Rheumatology 
of the Ontario Medical Association. "This approval gives healthcare providers 
an important new option to help patients manage their pain so they can get 
back to doing the activities they enjoy." 
OA is a progressive disease that occurs when damaged joint tissues are unable 
to normally repair themselves, resulting in a breakdown of cartilage and 
bone. The most commonly affected joints are the hands and weight-bearing 
joints, including the knees, hips, feet and spine. 
It is believed that Cymbalta helps enhance the body's natural pain suppressing 
system by increasing the activity of serotonin and norepinephrine in the brain 
and spinal cord. 
Safe and Effective
Taken once daily, the safety and efficacy of Cymbalta in the management of 
chronic pain associated with OA of the knee was established in two, 
randomized, double-blind, placebo-controlled clinical trials. 
Patients randomized to Cymbalta or placebo in a 13-week clinical trial started 
treatment at a dose of 30mg once daily for one week, then increased to 60mg 
once daily. After seven weeks of treatment, patients with sub-optimal response 
to treatment (<30 per cent pain reduction) had their dose increased to 120mg 
for the remainder of the study, while the remaining patients who responded 
continued on Cymbalta 60mg once daily. For efficacy analyses, data from both 
Cymbalta doses were combined and compared to placebo. Patients administered 
Cymbalta 60/120mg once daily reported significantly greater pain reduction 
compared to those on placebo.( ) 
In a 10-week, placebo-controlled, flexible-dose study, patients with OA pain 
of the knee, who had inadequate pain relief from an optimized dose of 
non-steroidal anti-inflammatory drug (NSAID) therapy for two weeks, received 
60/120 mg/day of Cymbalta or placebo. After eight weeks of double-blind 
treatment, patients treated with Cymbalta added to NSAID experienced 
significantly greater pain reduction compared with placebo. 
Furthermore, the studies also showed Cymbalta to be safe and well-tolerated. 
The most commonly observed adverse events in Cymbalta-treated OA patients 
included nausea, constipation, dry mouth, fatigue, diarrhea, abdominal pain, 
dizziness, insomnia, decreased appetite, and erectile dysfunction. Patients 
may take Cymbalta with or without food; however, food may help to reduce the 
incidence of initial nausea. The recommended starting dose for Cymbalta is 
60mg per day. 
Osteoarthritis in Canada
Osteoarthritis is the most common form of arthritis. In fact, one in eight 
Canadians live with it and almost everyone over 65 years of age has OA in at 
least one joint.( )Nearly 1 in 100 (or 300,000) Canadian adults (age 20+ 
years) have experienced at least moderate to severe pain due to OA.( ) 
Among all cases of OA, it is estimated that 40 per cent of patients have 
moderate to severe hip and/or knee OA. 
About Eli Lilly Canada Inc.
Lilly, a leading innovation-driven corporation, is developing a growing 
portfolio of 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 more than 500 people across the country. Additional 
information about Eli Lilly Canada can be found at 
® Registered trademark owned by Eli Lilly and Company; used under license. 
i   Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, et al. OARSI-FDA initiative:
defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May 19(5):478-82
Epub 2011 Mar 23
ii   Living Well with Osteoarthritis, Knowing your Treatment Options accessed: October 18,
iii  Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
iv  Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
v   Frakes EP, Risser RC, Hochberg MC, Wohlreich MM, et al. Duloxetine added to oral nonsteroidal anti-inflammatory 
drugs for treatment of knee pain due to
osteoarthritis.  Current Medical Research and Opinion, 2011: 27:12 2361-2372
vi  Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
vii  Arthritis Network. Impact of Arthritis.
Accessed  September 11, 2012.
viii Ibid.
ix   Ibid. 
Tonya Johnson Cohn & Wolfe 647.259.3282  Helen 
Stone Eli Lilly Canada Inc. 416-693-3169 
SOURCE: Eli Lilly Canada Inc. 
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-0- Nov/07/2012 13:00 GMT
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