BioCentury
ARTICLE | Clinical News

Contrave: SPA received

February 13, 2012 8:00 AM UTC

Orexigen said it reached an agreement with FDA on an SPA for the cardiovascular outcomes trial of obesity product Contrave that the agency requested in a complete response letter last year (see BioCentury, Feb. 7, 2011). The trial, expected to begin in late 2Q12, will enroll about 10,000 patients. An interim analysis and NDA resubmission are planned after about 87 MACE events, which Orexigen expects to occur less than 2 years after the trial start.

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 had 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). ...