Ranexa MERLIN study complete
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
CV Therapeutics expects top-line data from its MERLIN study of Ranexa (ranolazine) in the first quarter of 2007. The firm announced Sept. 26 that MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) is complete and will soon move to the close-out phase. MERLIN was designed under a special protocol assessment with FDA; the agreement stipulates that if the primary endpoint of time to first occurrence of any element of a composite endpoint is met, Ranexa could potentially be approved for treatment of ACS and secondary prevention. CVT has also said it believes MERLIN would support a labeling expansion to first-line angina (1Pharmaceutical Approvals Monthly May 2005, p. 10)...