Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Obstetrics/Gynecology | Rheumatology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pharmacia, Pfizer
Approval Status: Approved November 2001
Treatment Area: Osteoarthritis, rheumatoid arthritis and menstrual pain
Bextra is approved to treat the signs and symptoms of
osteoarthritis (OA), adult rheumatoid arthritis (RA) and the
treatment of pain associated with menstrual cramping. Bextra has
previously been approved for relief from arthritis pain. Bextra is
a once-daily treatment in an oral tablet formulation.
More than 23 million Americans suffer from some form of
arthritis. The most prevalent is OA, which affects approximately 21
million Americans. This chronic disorder is characterized by the
degeneration of joint cartilage and bone, which can lead to severe
pain and stiffness. RA, which affects joint lining, cartilage and
bone, affects over two million Americans.
The approval of Bextra is supported by results from clinical
studies lasting from three to six months. In five double-blind
trials with 3,918 subjects with OA of the knee or hip, Bextra was
significantly superior to placebo and comparable to a naproxen
control, in treating pain and stiffness and improving functional
measures. In four double-blind trials with 3,444 subjects with RA,
Bextra demonstrated significantly better results than placebo and
comparable results to naproxen in improving the tenderness and
number of swollen joints and the level of pain. Bextra was
evaluated for treatment of menstrual pain in two placebo-controlled
studies. The onset, magnitude and duration of analgesic effect of a
20 mg dose of Bextra was comparable to a 500 mg dose of
naproxen.
In all studies, Bextra was overall well tolerated and exhibited
a significantly better gastrointestinal safety profile than other
conventional nonsteroidal anti-inflammatory drugs (NSAIDs), such as
naproxen, ibuprofen and diflonac.
Adverse events associated with the use of Bextra may include
(but are not limited to) the following:
- Dyspepsia
- Headache
- Abdominal pain
- Nausea
- Diarrhea
Bextra (valdecoxib) is an NSAID that exhibits anti-inflammatory,
analgesic and antipyretic properties. These effects are due to the
inhibition of COX-2, which in turn inhibits prostaglandin
synthesis.
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