Etoricoxib (brand name Arcoxia®) is a new COX-2 selective inhibitor from Merck & Co. The FDA is requiring additional safety and efficacy data for etoricoxib before it will issue approval. It has been registered in some European countries, e.g. the United Kingdom. This article needs cleanup. ... The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ... World map showing location of Europe A satellite composite image of Europe Europe is geologically and geographically a peninsula, forming the westernmost part of Eurasia. ...
Etoricoxib is an investigational medicine under development at Merck that is designed to specifically inhibit the cyclooxygenase-2 (COX-2) enzyme.
The duration of pain relief was significantly longer for all doses of etoricoxib and ibuprofen compared to placebo as estimated by the median time to use of rescue medication by patients.
Specifically, the median time to rescue medication for etoricoxib 120, 180 and 240 mg was greater than 24 hours, for etoricoxib 60 mg it was approximately 12 hours, for ibuprofen it was approximately 10 hours and for placebo it was approximately two hours.
In one study, etoricoxib 90 mg demonstrated efficacy that was statistically superior to naproxen 1,000 mg for all primary endpoints and all additional endpoints including the ACR20.
In the other study, etoricoxib demonstrated efficacy that was similar to naproxen, and in patient with the ankylosing spondylitis, we performed a single pivotal double-blind, placebo and active comparator-controlled study which enrolled approximately 390 patients.
Over the 52-week treatment period, etoricoxib demonstrated efficacy that was statistically superior to naproxen 1,000 mg for all 3 co-primary endpoints, and in patient with acute gouty arthritis, we performed 2 double-blind, active comparator-controlled studies enrolling approximately 350 patients in total.
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