FDA requests additional Ranexa Phase III trial
Executive Summary
Approval of CV Therapeutics' Ranexa (ranolazine) depends on outcome of additional Phase III angina trial comparing combination of Ranexa with Pfizer's Norvasc (amlodipine) versus Norvasc alone. Study designed under FDA's special protocol assessment program will involve 500 refractory chronic angina patients. Ranexa has been "approvable" at FDA since Oct. 30, 2003; the trial follows an FDA advisory committee recommendation from December (1"The Pink Sheet" Dec. 15, 2003, p. 42). Enrollment will start in the third quarter and be completed by the end of 2005, company says...
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