COX-2 withdrawal - Therapeutic, R&D and pharmaceutical impact

As hurricane season continues in the US, forces of a very different nature have blown through the pharmaceutical industry with Merck's withdrawal of the blockbuster Vioxx (Rofecoxib) from the market. This move was in response to new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo. So what will be the impact of this key pharmaceutical event? Pfizer have affirmed the safety of their COX-2 inhibitor Celebrex (celecoxib); the FDA has stated that they will now be looking at other COX-2 inhibitors more carefully impacting on newer agents such as Merck's Arcoxia, and Novartis' Prexige; and others are suggesting that now is the time to push forward other therapeutic classes that can reduce the pain of osteoarthritis such as the NO-NSAIDs and LOX/COX inhibitors as well as osteoarthritis disease modifying agents. As the dust settles LeadDiscovery is publishing a special report on the impact of Vioxx's withdrawal. 

For details on this report click here