The pharmaceutical company Orexigen Therapeutics reached an agreement with the U.S. Food and Drug Administration for a heart-safety trial of the obesity drug Contrave. Regulatory officials worry that the previously rejected experimental drug may increase cardiovascular risks, which the placebo-controlled trial has been designed to measure.
The trial will enroll 10,000 patients and will study the long-term affects of Contrave on the heart. The trial has been designed under a “special protocol assessment” from the FDA, which indicates that the agency approves of that trial. If the trials succeed in showing that there in no increased danger of cardiovascular events associated with the diet drug, it is expected that Contrave will be approved. Orexigen has partnered with Takeda Pharmaceutical Co. to help develop the drug for the U.S., Mexico and Canada.