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 As Vioxx entered 2001, it quickly became a market leader in the $10 billion global market for treatment of pain and arthritis. It moved past the $2 billion sales mark faster than any other product in Merck’s history. The growth of the COX-2 market slowed mid-year, as did sales of Vioxx, but it is back on a growth trajectory.
Pain relief and gastrointestinal (GI) safety continue to be the primary needs in the arthritis and pain market. Vioxx is now available in 68 markets around the world as a once-a-day treatment for osteoarthritis, acute pain and dysmenorrhea and, in some countries outside the United States, for rheumatoid arthritis.
Physicians are responding favorably to the Company’s pain studies in which Vioxx 50 mg was compared to acetaminophen in combination with either codeine 60 mg or oxycodone 5 mg, which are commonly prescribed narcotics.
In the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, Vioxx
50 mg – a dose two times the highest chronic dose approved for
osteoarthritis – significantly reduced the risk of serious GI side
effects by half compared to a commonly used dose of naproxen (1,000 mg)
in rheumatoid arthritis patients. Vioxx is not indicated for rheumatoid
arthritis in the United States.
In VIGOR, 0.5 percent of patients on Vioxx had a heart attack compared to 0.1 percent on the comparator drug naproxen. Alternative interpretations have been proposed for the difference in the rates of heart attacks in the group treated with Vioxx in comparison with the group treated with naproxen. Explanations that have been proposed include that Vioxx increased the heart attack rate or naproxen decreased the heart attack rate. Although the underlying reason for the difference has not been established in prospectively designed clinical studies, Merck scientists believe the weight of evidence supports the theory that naproxen decreased the heart attack rate.
Outside the United States in the fourth quarter, Vioxx was approved for two new indications in the European Union (E.U.):
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In November, the medicine was approved for symptomatic relief in the treatment of adult rheumatoid arthritis in all E.U. member states through the mutual recognition procedure. |
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In December, Vioxx, under the trade names Ceoxx or Vioxx Acute, was approved for relief of acute pain and pain from dysmenorrhea in 13 member states of the E.U. |
In addition, an initiative with U.S. hospitals resulted in a favorable formulary
status for Vioxx at more than 3,000 hospitals. |
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As Vioxx entered 2001, it quickly became a market leader in the $10 billion global market for treatment of pain and arthritis. It moved past the $2 billion sales mark faster than any other product in Merck’s history. The growth of the COX-2 market slowed mid-year, as did sales of Vioxx, but it is back on a growth trajectory.