CV Therapeutics, Inc.’s MERLIN TIMI-36 study of Ranexa® (ranolazine extended-release tablets), has been given the go signal by the Data Safety Monitoring Board (DSMB) (the study’s overseer) to go ahead as planned.
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) is the study evaluating the efficacy and safety of Ranexa during acute and long-term treatment in (approximately 6,500) patients with non-ST elevation ACS treated with standard therapy.
In lieu of a special protocol agreement (SPA) with the USFDA, even if the primary endpoint is not met as long as treatment with Ranexa in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, the product has the chance to be approved as first-line chronic angina therapy.
But if primary endpoint is met, Ranexa could potentially be approved for treatment of acute coronary syndromes (ACS) and secondary prevention.
Read more at CVT Press Release.
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