MK-0524B is a combination of MK-0524A and Zocor (simvastatin) which would provide the proven cardiovascular benefits of two widely recognized agents in a single tablet. MK-0524A is an investigational compound being developed for the treatment of atherosclerosis by raising good cholesterol and lowering bad cholesterol.
Late-stage clinical trials to support MK-0524B continue as the company continues to work on developing the fixed-dose combination formulation.
A new filing date for the fixed-dose combination of MK-0524B has not been determined.
Merck also confirmed that the clinical development program for MK-0524A continues unchanged, and the company remains committed to filing MK-0524A in 2007. Oxford University announced in May 2006 it will conduct an international study, with MK-0524A plus simvastatin to investigate the benefit of the co-administration on cardiovascular disease. Preparations for patient enrollment continue as planned.
Merck reported its regulatory filing plans for MK-0524B in December 2005. The company notified investigators in February 2006 that the MK-0524B phase III program would continue with MK-0524A co-administered with simvastatin because of formulation issues with the fixed-dose combination.