BioCentury
ARTICLE | Clinical News

Contrave: Phase III ongoing

July 16, 2012 7:00 AM UTC

Orexigen said it is enrolling patients faster than originally projected in the long-term, double-blind, placebo-controlled, U.S. Phase III (Light Study) trial, which is assessing the cardiovascular health outcomes of Contrave in up to 10,000 patients. Orexigen said it now expects to complete enrollment of the number of patients required for an interim analysis in 1Q13. The company said with the revised enrollment projections, it expects the trial to reach 87 MACE events in 2H13, at which point an interim analysis and NDA resubmission are planned. Orexigen said it is targeting to enroll a patient population with a 1.5% annualized background rate of MACE. In June, the company started the Light Study and said it expected to reach 87 MACE events in the trial less than 2 years after the trial start (see BioCentury, June 11). FDA requested the assessment of CV health outcomes for Contrave in a complete response letter last year. The company has an SPA from FDA for the trial, which has enrolled over 1,500 patients (see BioCentury, Feb. 7, 2011 & Feb. 13, 2012).

Last September, Orexigen resumed development of Contrave after the company and FDA reached an agreement for a smaller CV outcomes trial than the company had initially estimated. Orexigen suspended development of Contrave in June after the company said it would need to conduct a CV outcomes trial in 60,000-100,000 patients (see BioCentury, June 6, 2011 & Sept. 26, 2011). ...