Home » Drug Information » FDA Approved Drugs » 2004
Medical Areas: Musculoskeletal | Rheumatology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
Treatment Area: Rheumatoid arthritis
Vioxx is a nonsteroidal anti-inflammatory drug that inhibits
cyclooxygenase-2 (COX-2). The COX-2 enzyme controls the conversion
of arachidonic acid into prostaglandin E2, a hormone that produces
Vioxx has most recently been approved for the relief of the
signs and symptoms of rheumatoid arthritis in adults. The drug was
initially approved in 1999 for the relief of osteoarthritis, the
management of acute pain in adults, and the treatment of primary
dysmenorrhea (menstrual pain).
Vioxx is available as a tablet or in a liquid formulation.
UPDATED: WITHDRAWN OCTOBER 2004
Vioxx was evaluated as an effective treatment for rheumatoid
arthritis (RA) in two 12-week, placebo- and active-controlled
trials that included approximately 2,000 subjects. Results
demonstrated that Vioxx was superior to a placebo in the following
measurements: number of tender joints, number of swollen joints,
and patient and physician global assessments of disease activity.
Additionally, Vioxx was more effective than placebo according to
the American College of Rheumatology 20% (ACR20) Responder Index.
In terms of the active control, Vioxx 25 mg once daily was
generally similar to naproxen 500 mg twice daily in the treatment
Vioxx was evaluated in placebo- and active-controlled trials for
the treatment of osteoarthritis (OA) of the knee and hip. The
trials enrolled approximately 3,900 OA subjects and were six to 86
weeks in duration. Treatment with Vioxx 12.5 mg and 25 mg once
daily produced improvement in patient and physician global
assessments and in the WOMAC (Western Ontario and McMaster
Universities) osteoarthritis questionnaire. In all OA clinical
studies, once-daily treatment in the morning with Vioxx 12.5 mg and
25 mg was associated with a significant reduction in joint
stiffness upon first awakening in the morning. Additionally, Vioxx
(at 12.5 mg and 25 mg doses) was shown to be comparable to
ibuprofen 800 mg TID and diclofenac 50 mg TID in the treatment of
the signs and symptoms of OA.
Analgesia/Pain Relief (including
Vioxx was shown to relieve pain in acute analgesic models of
post-operative dental pain, post-orthopedic surgical pain, and
primary dysmenorrhea. The effect of a single 50-mg dose of Vioxx in
providing pain relief was generally similar to 550 mg of naproxen
sodium or 400 mg of ibuprofen. A single 50-mg dose of Vioxx
produced an onset of pain relief within 45 minutes in single-dose
post-operative dental pain studies. In a multiple-dose study of
post-orthopedic surgical pain, subjects received Vioxx or a placebo
for up to five days. Study results demonstrated that 50 mg of Vioxx
once daily was effective in reducing pain, and Vioxx-treated
subjects took a significantly smaller amount of additional pain
medication than subjects treated with placebo.
Side effects reported with Vioxx have included (but are not
limited to) the following:
- Upper respiratory infection
- Back pain
- Urinary tract infection
Additionally, rare but serious side effects have been reported
in patients receiving Vioxx and/or related medications. These
include stomach problems, such as stomach and intestinal bleeding,
heart attacks, allergic reactions and skin reactions.
Mechanism of Action
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities
in animal models. The mechanism of action of Vioxx is believed to
be due to inhibition of prostaglandin synthesis, via inhibition of
cyclooxygenase-2 (COX-2). At therapeutic concentrations in humans,
Vioxx does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
(from Vioxx Prescribing Information)
For additional information on Vioxx, please visit the product
web site at www.vioxx.com.