Merck Moves forward with Vioxx Successor--Arcoxia

Merck Looks Forward To Reviewing The MEDAL Program Data With Regulatory Agencies And Intends To Respond To FDA-Issued ''Approvable'' Letter

Merck & Co., Inc. announced today that preliminary analyses indicate the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program showed that the rate of confirmed thrombotic cardiovascular (CV) events was similar between the selective COX-2 inhibitor ARCOXIA(TM) and diclofenac, a traditional nonsteroidal anti-inflammatory drug (NSAID). Specifically, in the pre-specified "per-protocol" analysis of the primary endpoint, the relative risk of confirmed thrombotic CV events between ARCOXIA and diclofenac was 0.95 (95 percent CI: 0.81, 1.11). In the "intent-to-treat" analysis, the relative risk of confirmed thrombotic CV events between ARCOXIA and diclofenac was 1.05 (95 percent CI: 0.93, 1.19), consistent with the primary per-protocol analysis.


Merck is seeking indications for Arcoxia for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis. Arcoxia is a selective COX-2 inhibitor (cyclooxygenase 2- an enzyme that is involved in the inflammatory pathway.) This drug is a NSAID, non steroidal anti inflammatory drug, like Advil. It selectively inhibits COX-2 and not COX-1 so that the intestinal tract isnt irritated.
I'll post the heart related data a little later, pretty interesting. Looks really safe.

Merck closed today up 0.38 cents to $41.18