Research and Markets: October 2004 Meant the Withdrawal of the Blockbuster Vioxx/Rofecoxib from the Market.

DUBLIN, Ireland -- 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 Has Been Stopped, Was Designed to Evaluate the Efficacy of Vioxx in Preventing Recurrence of Colorectal Polyps in Patients with a History of Colorectal Adenomas

Research and Markets (http://www.researchandmarkets.com) has announced the addition of COX-2 withdrawal - Therapeutic, R&D and pharmaceutical impact to their offering.

In this study, there was an increased relative risk for confirmed cardiovascular events, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo. In the wake of Merck's announcement Pfizer affirmed the safety of their COX-2 inhibitor Celebrex; the FDA and European regulators 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 and rheumatoid disease modifying agents. Accompanying these changes will be a realignment of the COX-2 inhibitor market.

The report was written to help all involved in drug development sector to:

--Fully understand the original rational behind the development of COX-2 inhibitors

--Evaluate pharmacological and clinical data surrounding Vioxx, remaining COX-2 inhibitors on the market, and drugs in development

--Understand the exact nature of the cardiovascular risk of the COX-2 inhibitors

--Differentiate between the efficacy, gastrointestinal safety and cardiovascular risk of the COX-2 inhibitors

--Predict the future sales of COX-2 inhibitors

--Introduce alternatives for COX-2 inhibitor indications.

The report opens with a detailed discussion of the eicosanoid pathway and the (patho)physiological role of the various products of the cyclooxygenase pathway. The report continues with an account of the discovery that aspirin acts through the inhibition of COX and the rational development of improved non-selective COX inhibitors.

The contents of this report is as follows:

1. The biology of the cyclooxygenase pathway

2. The rational for COX-2 development

3. Clinical data on approved and late stage COX-2 inhibitors

4. The market for COX-2 inhibitors

5. Adverse effects of COX-2 inhibitors

6. Differentiating the risk of COX-2 inhibitor family members

7. Knock-on effect of Vioxx's withdrawal - Estimated sales performance of other

8. Emerging alternatives to COX-2 inhibitors

For more information visit http://www.researchandmarkets.com/reports/c8160