April 15, 1999
Health Canada has approved Searle Canada's and
Pfizer Canada Inc.'s Celebrex(TM) (celecoxib) for acute and chronic use in the
relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid
arthritis (RA) in adults.
Celebrex received priority review from Health Canada and will be available by
prescription in Canada by April 27, 1999. Since its introduction in the United
States in January of this year, Celebrex has become one of the fastest selling
new drugs in history.
Celebrex is an important treatment option for the more than four million
Canadians with arthritis. Celebrex was tested in clinical trials that involved
over 13,000 patients and healthy volunteers enrolled in more than 50 different
clinical studies in 23 countries world-wide, including more than 1,900 Canadian
participants at 152 Canadian sites.
In clinical trials, Celebrex was shown to be as effective as the maximum
prescription-strength non-steroidal anti-inflammatory drugs (NSAIDs) naproxen
and ibuprofen in treating arthritis pain and inflammation. In OA patients,
Celebrex improved pain, stiffness and patient functions, such as walking,
bending and getting in and out of a car. Importantly, Celebrex was associated
with significantly fewer upper gastrointestinal (GI) ulcers than
traditionally-used arthritis medications naproxen and ibuprofen.
"The approval of Celebrex in Canada will change the way arthritis care is
currently practised in this country," said Dr. Bill Bensen, a Hamilton
rheumatologist who, as lead Canadian investigator, has seen more patients in
open-label and double-blind clinical trials than at any other site world-wide.
"Safety is obviously a key advantage to Celebrex but its unique mechanism
of action actually offers patients and doctors other benefits over existing
therapies.
"First, it's a team player, demonstrating no clinically significant
drug-drug interactions with other therapies commonly taken by arthritis
patients. Second, unlike current NSAID therapies, it had no effect on platelet
aggregation or bleeding time, eliminating increased concerns for patients who
are taking blood thinners either chronically or acutely, such as after an
operation. I saw Celebrex change my patients' lives in clinical trials."
Designed using advanced molecular technology, Celebrex is clearly
differentiated from traditional NSAIDs because of its innovative mechanism of
action. Celebrex is the first arthritis medication to target and block the
COX-2 enzyme that plays a role in causing arthritis pain and inflammation,
without blocking the COX-1 enzyme that protects the gastrointestinal system.
Previously available NSAIDs inhibit both enzymes, relieving pain and
inflammation but potentially damaging the stomach lining, which can lead to
ulcers in some patients.
The recommended therapeutic dose of Celebrex for OA is 200 mg daily
administered as a single dose or 100 mg twice daily. For RA, the recommended
therapeutic dose is 100 mg to 200 mg, twice daily. Arthritis is one of Canada's
most chronic, debilitating and costly illnesses, affecting more than four
million Canadians, or one in seven people, at an estimated cost of $5.9 billion
annually. The most common cause of long-term disability in Canada, arthritis
accounts for more than 25 per cent of all long-term disability cases. It is the
cause of disability for more than 600,000 Canadians of which 75 per cent are
dependent on others because of their condition.
Two million Canadians take NSAIDs to treat the symptoms of arthritis.
Approximately 20 to 30 per cent of the patients who take NSAIDs develop
persistent gastrointestinal symptoms and an estimated 20,000 Canadians
experience severe problems such as GI perforations and bleeding. More Canadians
die each year from NSAID complications than do those from multiple-vehicle
accidents, fires and gunshot-related homicides combined.
Arthritis is a chronic condition characterised by pain and inflammation of the
joints (such as knees, hips, fingers, feet, spine and shoulders). The most
common type of arthritis, osteoarthritis, is a degenerative joint disease in
which cartilage that covers the ends of the bones in the joint deteriorates,
causing pain, inflammation, and loss of movement.
Rheumatoid arthritis is a disease of unknown cause in which the joint lining
becomes inflamed as part of excessive immune system activity. Rheumatoid
arthritis often results in destruction of the joint, pain and disfigurement,
and limits the normal range of motion of the affected joint.
"This is a very significant and exciting step forward because it's the
first major advance in arthritis medication that we've seen in a number of
years," said Denis Morrice, president and CEO, The Arthritis Society.
"Basically it means that Canadians suffering from arthritis no longer have
to fear the serious side effects of their medications. For many years that fear
has been a major concern, for both patients and doctors, so this is fantastic
news."
In clinical studies, the most common GI side effects of Celebrex were
dyspepsia, diarrhea and abdominal pain. Discontinuation due to each of these
side effects was less than one percent. Patients who have a known allergic
reaction to celecoxib, sulfonamides, aspirin or NSAIDs should not use Celebrex.
Although Celebrex has a low potential for stomach ulcers, serious GI tract
ulcerations can occur without warning symptoms. Physicians and patients should
remain alert for signs and symptoms of GI bleeding.
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