Powerful new analgesic anti-inflammatory
for aerhritis and menstrual pain
BEXTRA® receives Health
Canada Approval
TORONTO,
ON (January 28, 2003) - Health Canada has given its approval for
BEXTRA® (valdecoxib tablets), a new analgesic anti-inflammatory,
indicated for the acute and chronic treatment of the signs and symptoms of
adult rheumatoid arthritis (RA) and osteoarthritis (OA) as well as the
relief of pain associated with primary dysmenorrhea, or painful menstrual
cramping.
BEXTRA
is now available by prescription through pharmacies across Canada. A
once-daily dose of BEXTRA has a rapid onset of action - as early as 30
minutes for primary dysmenorrhea and as early as day one for
osteoarthritis. At the recommended dosage of 10 mg once daily, BEXTRA
offers sustained 24-hour relief of the pain and inflammation associated
with OA and RA, including the pain of debilitating RA flare-ups. Some OA
and RA patients may benefit from 20 mg once a day. For pain associated
with primary dysmenorrhea, the dose is 40 mg once daily.
The
chronic nature of OA pain highlights the need for new analgesic anti-inflammatories,
such as BEXTRA. "In arthritis management, there is often either
considerable switching of therapies or co-prescribing of medications, such
as narcotic analgesics, to effectively manage difficult arthritis pain and
inflammation," said Dr. Carter Thorne, Medical Director, The
Arthritis Program, Southlake Regional Health Centre, Newmarket, ON.
"By providing powerful arthritis pain relief, BEXTRA offers an
excellent new alternative for patients who are not receiving adequate pain
relief."
More
than four million Canadians have some form of arthritis. Among the various
forms, OA is the most prevalent, affecting 3 million (1 in 10) Canadians.
Characterized by the degeneration of joint cartilage and adjacent bone, OA
is a chronic disorder that can cause pain and joint stiffness. RA, which
affects 300,000 (1 in 100) Canadians, is a painful autoimmune inflammatory
disease that affects primarily joint lining, cartilage and bones, leading
to joint destruction.
As
a coxib, a unique agent that spares the enzyme that protects the
gastrointestinal (GI) system (COX-1) while targeting the enzyme that plays
a role in causing pain and inflammation (COX-2), BEXTRA provides powerful
arthritis pain relief while demonstrating an excellent upper GI safety
profile compared to traditional NSAIDs. In clinical trials lasting three
to six months, BEXTRA (10 mg once daily), was as effective as commonly
prescribed doses of the traditional NSAIDs studied, and three studies of
12 to 14 weeks duration also demonstrated that BEXTRA 10 mg once-daily was
associated with a statistically lower incidence of endoscopically-detected
gastroduodenal ulceration versus traditional NSAIDs. The advantages of
BEXTRA appear to be maintained in patients with risk factors for
gastroduodenal ulcers.
BEXTRA
was discovered by Pharmacia Corporation and is being co-promoted globally
with Pfizer Inc. "We are proud of our strong heritage in arthritis
treatment and care, which continues with the launch of BEXTRA," said
Mike Cloutier, President, Pharmacia Canada Inc.
"BEXTRA
raises the bar in effectively treating the debilitating symptoms of
arthritis," noted Jean-Michel Halfon, President and CEO, Pfizer
Canada Inc. "It also reaffirms our commitment to bringing Canadians
new medications that help them live healthier and more productive
lives."
Effective
Arthritis Treatment BEXTRA was demonstrated to be as effective as
ibuprofen (800 mg three times daily), diclofenac (75 mg twice daily) and
naproxen (500 mg twice daily), for treating the signs and symptoms of OA,
and as effective as naproxen (500 mg twice daily) for treating the signs
and symptoms of RA.
BEXTRA
was used in five double-blind randomized, controlled trials to evaluate
treatment for the signs and symptoms of OA of the knee or hip. In the two
12-week pivotal trials, BEXTRA, at 10 mg and 20 mg, demonstrated pain
relief within 24 hours of the first dose. In treating OA and RA, BEXTRA
has shown sustained efficacy in clinical trials up to one year.
In
a study led by Canadian rheumatologist Dr. William Bensen, a clinical
rheumatologist at McMaster University in Hamilton, 1,098 patients with RA
randomly received BEXTRA at 10 mg, 20 mg, or 40 mg once daily, standard
therapeutic doses of naproxen (500 mg twice daily), or placebo (twice
daily) for 12 weeks. A once-daily 10 mg dose of BEXTRA demonstrated
efficacy similar to naproxen twice a day in reducing moderate-to-severe RA
pain. Further, BEXTRA reduced the duration of morning stiffness, a
crippling symptom of RA, by 49 per cent versus 37 per cent for naproxen
500 mg twice a day.
Relief from Menstrual Pain
In
two placebo-controlled studies of menstrual pain, the magnitude and
duration of the analgesic effect with BEXTRA 40 mg was comparable to
naproxen sodium 550 mg twice a day as needed. More than 80 per cent of
women took only a single 40 mg dose of BEXTRA in the first 24 hours for
relief of menstrual pain. An estimated 50 per cent of menstruating women
between the ages of 18 and 45 suffer from menstrual pain.
"The
pain associated with primary dysmenorrhea can be extremely debilitating,
preventing women from carrying on with daily activities," said Dr.
Fay Weisberg, Assistant Professor, University of Toronto, Obstetrics and
Gynecology Sunnybrook and Women's College Hospital. "The rapid onset
of BEXTRA provides welcomed fast and effective relief for women suffering
from moderate to severe menstrual pain."
Safety and To
lerability
In
an extensive clinical program submitted to Health Canada, BEXTRA was
studied in 62 global clinical trials that involved more than 14,000
individuals, including 1,035 Canadian patients at 98 clinical trial sites
across the country.
The
GI safety of BEXTRA was compared to that of the traditional NSAIDs studied
(ibuprofen, diclofenac and naproxen). BEXTRA was well tolerated with an
overall upper GI safety profile significantly better than the traditional
NSAIDs, as demonstrated by fewer perforations, obstructions and GI bleeds.
The
most common adverse events observed were dyspepsia, headache, abdominal
pain, nausea and diarrhea. In controlled clinical trials, the incidence of
dyspepsia (stomach upset) among OA and RA patients taking BEXTRA at 10 or
20 mg and above therapeutic dosing at 40 mg was lower than for those
taking traditional NSAIDs. Additionally, the data show that at therapeutic
doses, BEXTRA demonstrates a cardiovascular and cardiorenal safety profile
similar to placebo, naproxen, ibuprofen, and diclofenac.
In
one placebo-controlled study of OA patients, the incidence of
endoscopically-detected gastroduodenal ulcers with BEXTRA 10 mg was three
per cent, similar to placebo (four per cent) and approximately one third
of that seen with naproxen 500 mg twice daily (10 per cent).
In
a second placebo-controlled study of OA patients, BEXTRA 10 mg again
demonstrated an incidence of endoscopically-detected gastroduodenal ulcers
similar to placebo (four per cent), which was approximately one-third that
observed with either ibuprofen 800 mg three times daily (14 per cent) or
diclofenac 75 mg twice daily (13 per cent).
In
a 14-week study in RA patients, BEXTRA, at supratherapeutic doses of 20 mg
or 40 mg twice daily, demonstrated a rate of endoscopically-detected
gastroduodenal ulcers (seven per cent) that was approximately one-third of
that seen with naproxen 500 mg twice daily (20 per cent).
Patients
who have a known hypersensitivity or allergic reaction to valdecoxib,
sulfonamides, aspirin or NSAIDs should not use BEXTRA. As with all NSAIDs,
serious GI ulcerations can occur without warning. Physicians and patients
should remain alert to the signs and symptoms of GI bleeding.
In
addition, similar to all NSAIDs including COXIBs, BEXTRA is
contraindicated in: active peptic ulceration, active GI bleeding, or
active inflammatory disease of the bowel; significant liver impairment or
active liver disease; and severe kidney problems.
Rare
serious skin reactions, including exfoliative dermatitis, Stevens-Johnson
syndrome, and toxic epidermal necrolysis, have been reported through
post-marketing surveillance in patients receiving BEXTRA.
As
these reactions can be life threatening, BEXTRA should be discontinued at
the first appearance of skin rash or any other sign of hypersensitivity.
BEXTRA
should be used with caution in patients with heart failure, left
ventricular dysfunction, hypertension, edema from any cause or other
conditions predisposing to fluid retention.
BEXTRA,
co-marketed in Canada by Pharmacia Canada and Pfizer Canada Inc., is the
second product to emerge from the Pharmacia/Pfizer coxib portfolio.
Pharmacia
Canada is passionate in its pursuit of new medicines and treatments to
improve health and wellness. The company employs more than 700 people
across the country and operates facilities in Mississauga, Montreal and
Vancouver. Pharmacia Canada invests significantly in Canadian research and
development and has a thriving community investment program.
The
company is part of Pharmacia Corporation (NYSE: PHA) a top-tier global
pharmaceutical firm that invests more than $3 billion annually in R&D.
Visit
www.pharmacia.ca <http://www.pharmacia.ca>. Pfizer Canada Inc. is
the Canadian operation of Pfizer Inc (NYSE: PFE), the world's leading
pharmaceutical company. Pfizer discovers, develops, manufactures and
markets leading prescription medicines for both humans and animals, as
well as many of the world's best-known over-the-counter healthcare
products. Pfizer Canada is one of the top 15 investors in Canadian
research and development, investing more than $132 million in 2001. Pfizer
Canada employs more than 2,300 persons across Canada.
Headquarters of the Pfizer Pharmaceuticals Group in Canada are in Kirkland, Quebec. Global headquarters are located in New York City, where the company was founded in 1849. For more information, visit www.pfizer.ca.