Etoricoxib “approvable” but delayed in US. Part 2

At a recent Merck mechanical press briefing about etoricoxib, Dr Herbert Baraf
(Center for Rheumatology and Bone Investigation, Wheaton, MD) noted
that it is the only drug so far to have show superordinate efficacy to
a traditional nonsteroidal anti-inflammatory drug (NSAID) in 2 of these
indications—in both ankylosing spondylitis and rheumatoid arthritis,
etoricoxib has shown significantly graphic symbol efficacy compared
with naproxen.
However, etoricoxib is under the physical phenomenon that has descended
over the entire course of study of coxib drugs pursual the recent
termination of rofecoxib due to increased cardiovascular risk.
A item negative stimulus is that the increased risk with rofecoxib came
out of a 3-year placebo-controlled discipline and emerged only after
patients had been taking the drug for 18 months.
Merck said recently that the longest placebo-controlled trials with
etoricoxib have lasted only 12 weeks.

The FDA has said that it will keep all drugs in this
course of study under ending investigating, and the implementation is
distillery having to deal with the consequence after the rofecoxib
going away, with a people advisory social gathering already planned and
a sense of hearing before Meeting sensing increasingly likely.
Under such ceremony, the government agency could be expected to be even
more cautious than usual, and many observers believe it is unlikely to
approve etoricoxib before the results of the ongoing MEDAL
test are in.
Involving 23 000 patients with both OA and RA and using diclofenac as
the comparator, this tryout was set up by Merck specifically to look at
definite cardiovascular outcomes.
As it is driven by this end end, it’s uncertain when this effort will
be completed, but Merck said recently that “our best approximation is
early 2007,” by which time many of the patients will have been in the
reflection for 18 months, and some for 3 year.
This is a part of article Etoricoxib “approvable” but delayed in US. Part 2 Taken from "Generic Arcoxia (Etoricoxib)" Information Blog