Orexigen Suspends US Development of Obesity Drug Contrave until 2012

In previous issues, we’ve documented the arduous journey of Orexigen’s anti-obesity drug Contrave through the regulatory process. In December, an FDA Advisory Committee voted 13-7 in favor of approving Contrave. However, to the surprise of many in the industry, the FDA chose not to approve Contrave, citing the potential for cardiovascular side effects (increased heart rate and blood pressure) associated with use of the medication. Recently, Orexigen met with the FDA to discuss the design of a cardiovascular outcomes trial to alleviate these concerns. At this meeting, the FDA laid out its stringent requirements for an appropriate cardiovascular outcomes trial for Contrave, including enrollment of a massive trial population of 60,000-100,000 patients. Orexigen plans to file an appeal in response to the FDA’s requirements, but historically, these have proven ineffective. With the current FDA, we do not expect movement on this front at the present time due to the FDA’s burdensome request, and the fact that the agency’s requirements could change after it holds an advisory committee meeting in early 2012 on cardiovascular risk assessment for obesity drugs. As such, Orexigen has moved to suspend development of Contrave in the US. What a shame for patients. Meanwhile, the company will aggressively explore opportunities for weight-loss medications outside the US and look to acquire new lines of business. We were very discouraged by the FDA’s actions on this front. --AB