Orexigen’s Contrave Back in Development!

If you’ve been following our coverage of Orexigen’s obesity drug, Contrave, you’re likely aware that it has been through a regulatory rollercoaster over the past few months. After a committee of independent experts advised the FDA to approve the drug, the agency chose not to approve Contrave and laid out extremely burdensome requirements for approval, including an “outcomes trial” that would involve tracking cardiovascular events in 60,000-100,000 patients (see NewNowNext in diaTribe #34). The company halted development of Contrave and was uncertain whether it would have the financial capabilities to fulfill FDA’s demands. However, this past month, the FDA reversed its previous stance and offered Orexigen a clear, more feasible, and much less burdensome path to approval for Contrave. Specifically, the agency eased its criteria for the outcomes study and is allowing Orexigen to resubmit Contrave to the FDA based on interim results of the outcomes trial. Therefore, if results are positive from the study, Orexigen could resubmit Contrave by early 2014, which would position it for another FDA decision (and potential approval) before the end of the 2014. We expect to hear a more concrete timeline from Orexigen after it finalizes the details of the outcomes study with the FDA in the coming months. Overall, we are very encouraged by the FDA’s willingness to re-consider its previous decisions and hope this signals a greater shift within the organization toward encouraging the development of obesity drugs. --ST