Merck says a long-awaited arthritis drug, Arcoxia, will be filed with the Food and Drug Administration.
Merck today withdrew its application with the Food and Drug Administration for Arcoxia, its next-generation painkiller.
"We're very confident in the safety and efficacy of Arcoxia, " says Merck spokeswoman Christine Fanelle.
Nor is Merck's Arcoxia, which has been delayed for years, out of the woods.
Merck is also conducting such an outcomes trial for Vioxx and its follow-up drug, Arcoxia.
In hindsight, Merck's decision to ask the FDA to even consider Arcoxia is baffling.
So why did this company, which had better things to do, press forward with Arcoxia?
Arcoxia is not expected to be refiled with the FDA until the second half of 2003.
And the launch of Arcoxia, a successor to Vioxx, has been postponed in America.
Merck's Arcoxia study, begun in 2002, followed 44, 000 patients for a year and a half, on average.
The key for Arcoxia, Merck says, is that it be able to compete straight out of the box.
To help prove the heart safety of Arcoxia, Merck announced a 23, 542-patient trial called MEDAL in September 2002.
There were 35 heart attacks, strokes, or other cardiovascular events in the Arcoxia group, compared to 30 for diclofenac.
But Arcoxia patients were followed for, on average, nine months--and the risk would take longer than that to emerge.
Vioxx is more selective, and Arcoxia is the most selective of all, blocking out Cox-2 while not affecting Cox-1.
Therefore, as the thinking goes, there should be at least some signs that Arcoxia is bad for the heart.
The company says new data could result in Arcoxia being approved for a form of chronic back pain called ankylosing spondylitis.
At a December 2001 meeting with financial analysts, Merck promised to study the safety of Vioxx and a follow-up drug, Arcoxia.
Merck denies there's any such problem for either Vioxx or follow-up Arcoxia, and plans to conduct new studies to prove it.
Arcoxia is another Cox II inhibitor drug, however, and may face renewed scrutiny as a result of the problems associated with Vioxx.
Generally speaking, Arcoxia seems to raise hypertension by three millimeters of mercury.
In an effort to put those concerns to rest, it will conduct new safety studies on both Vioxx and its successor, Arcoxia.
He notes that in trials that compared Arcoxia to a placebo, there was no evidence of a significant increase in cardiovascular side effects.
Heart side effects have been a looming concern for Cox-2 inhibitors, the class of drugs to which Vioxx, Celebrex, Bextra and Arcoxia belong.
But Merck is expected to launch a new drug, Arcoxia, and the competition is expected to be heavier than it was from Vioxx.
Merck is conducting huge studies to prove that its current pain medication, Vioxx, and a next-generation pill, Arcoxia, are safe for the heart.
Even if the results don't help with Vioxx, they may help Merck market Arcoxia, a follow-on pill that many on Wall Street doubt.
On its conference call about the Arcoxia data, Merck said that a small number of people stopped taking the drug because of hypertension.
Patients received either Arcoxia or diclofenac, and there was no difference in the number of heart attacks, strokes or death, or major stomach bleeding.
In order to try and assuage fears about both Vioxx and Arcoxia, Merck has started massive outcomes trials, specifically looking for cardiac side effects.
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