Joint Pain Forum – News you can use!
Health Canada expands use of new COX-2 inhibitor Prexige
24-Jul-2007
Novartis Pharmaceuticals Canada Inc. announced today the expanded
Health Canada approval of Prexige(*) (lumiracoxib) for the acute and
chronic treatment of the signs and symptoms of
osteoarthritis (OA) in adults. Initially approved for OA of the knee in
November 2006, Prexige is a unique selective COX-2 inhibitor that
provides osteoarthritis patients with an effective and safe option for
controlling pain, improving their mobility and quality of life.(1)
"This new treatment is welcome news for many patients who have had no
choice but to endure the debilitating effects of osteoarthritis with
little relief from their pain," says Dr. Jameel Razack, a family
physician in Toronto. "With Prexige, we now have a much needed option
to offer our
osteoarthritis patients that can effectively and safely reduce their
joint pain and improve their mobility."
After living with osteoarthritis for many years, George Soteroff, a
Toronto business executive, had run out of options to control the pain
in his knees. Then, a few months ago, Mr. Soteroff's doctor prescribed
a new treatment that allowed him to take back control of his disease,
and his life.
"I was at the point where my knee pain was unbearable and the
only treatment left for me wasn't controlling it. I had run out of
options and it was very frustrating for me, and for my doctor," recalls
Mr. Soteroff. "
My entire life was affected - mornings were slowed down by pain and
stiffness, getting around during the day wasn't much easier, and
playing golf was very difficult."
Uncontrolled pain from OA can have a serious impact on a patient's
physical and emotional well-being, which can significantly reduce the
overall quality of life for the three million Canadians battling this
disease.(2)
These patients rely on a variety of treatment options to control their
pain, because not all respond to medications in the same way. But, in
recent years, effective and safe options to treat OA pain have become
increasingly limited, leaving more than one in five patients without
sufficient pain relief from their current non-steroidal
anti-inflammatory drug (NSAID) therapy.(3)
Most common form of arthritis
OA is the most common form of arthritis, impacting the lives of more than
three million Canadians (1 in 10). The disease affects the joints in the body
and usually involves the hands and weight-bearing joints such as hips, knees,
feet and spine. OA can occur at any age but most people develop it after the
age of 45. Symptoms usually come on slowly and include pain and stiffness or
swelling around the joints.(2)
"Uncontrolled osteoarthritis symptoms can lead to reduced mobility,
muscle deterioration and a further increase in joint pain," said John Fleming,
President and CEO, The Arthritis Society. "It is always a good day when new
treatment options become available for people with osteoarthritis. We urge
governments, as we always do to recognize the needs of people living with the
pain of arthritis to have timely access to all medications approved for use in
Canada."
In fact, many patients like George Soteroff depend on effective and safe
treatment options like Prexige to lead productive and active lifestyles.
"Once I started taking Prexige, I noticed immediate and significant
improvements, from first thing in the morning and lasting all day," says Mr.
Soteroff. "My knees are not sore and the joints are much looser. I walk
without a limp now, rather than a stagger, and I recently played nine holes of
golf, pulling a heavy golf cart up and down hills - a first in a couple of
years!" he adds.
About Prexige
Prexige works by blocking cyclooxygenase-2 (COX-2), an enzyme that
promotes joint inflammation, while sparing another similar enzyme called COX-1
which helps protect the mucous lining in the stomach, unlike traditional
NSAIDs. Prexige is considered unique because it is rapidly cleared from the
body, it reaches a higher concentration in the joint synovial fluid, and it is
preferentially retained in inflamed tissue, allowing for once per day
dosing.(4)
Prexige is the first COX-2 selective inhibitor to be approved in Canada
since the withdrawal of two medications in the same class, in 2004-2005.
COX-2s were first marketed in Canada in 1999 as anti-inflammatory medications
that caused less gastrointestinal side-effects (e.g. ulcers) than traditional
NSAIDs, such as ibuprofen.
Following the COX-2 withdrawals, several expert bodies in arthritis held
a consensus conference, in 2005, and identified a gap in pain relief for the
three million Canadians living with OA. This group, and the arthritis
community, concluded that patients need a variety of medications, including
COX-2 inhibitors, which are effective and safe.
Initially approved for OA of the knee in November, 2006, Prexige has the
largest body of evidence supporting the launch of an NSAID, traditional and
COX-2, with a clinical trial database of over 34,000 patients. In the
Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), the
largest safety outcomes study published in OA (18,325 patients), Prexige, at
four times the recommended OA dose, was compared to the traditional NSAIDs
ibuprofen and naproxen.(5,6)
TARGET found that Prexige provided a 79 per cent reduction in the
incidence of upper GI ulcer complications, among non-aspirin users, in
comparison to those treated with traditional NSAIDs naproxen and
ibuprofen.(5,6,7) The treatment also showed no significant difference in risk
of cardiovascular events, such as heart attack or stroke compared to the other
NSAIDs.(6)
Recent data presented at the 2007 Annual European Congress of
Rheumatology showed that Prexige has significantly less impact on blood
pressure than ibuprofen, a commonly-used NSAID.(8) These new results are
important because approximately 40 per cent of patients with osteoarthritis
also have high blood pressure (or hypertension).(9,10)
Novartis is committed to ensuring that Prexige is prescribed
appropriately and has launched a comprehensive, long-term study to monitor
20,000 Canadian patients on selected NSAIDs/COX-2 inhibitors, including
Prexige. This first-of-its kind, real-life study will further build on the
strong body of safety evidence available on Prexige. This commitment will be
further supported through strong health education programs for physicians and
pharmacists across the country.
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