- Although disclosure of interim evidence that Contrave (naltrexone) may prevent heart attacks (instead of causing them) should be a good thing, Orexigen broke FDA rules and Data Monitoring Committee protocol.
- Orexigen released the interim data without consulting Steven Nissen, chair of cardiology of Cleveland Clinic and lead investigator of the study in question.
- The study was planned by the safety committee for the Orexigen study under the leadership of Nissen and statistician Thomas Fleming. One of the stipulations was that interim data would not be released, as it could compromise the study. Orexigen will now have to conduct a second safety study.
This is, overall, good news for Orexigen—especially considering the longstanding concerns about the link between obesity drugs and heart attacks. In fact, the news was so positive that Orexigen has filed a patent for use of Contrave to prevent heart attacks and its stock has been spiking. The data in short: In a randomized, controlled study of 8,905 patients, there was a 40% reduction in risk of heart attack in Contrave-treated patients.
However, while that is excellent news and very important in the context of treating obese patients with multiple cardiovascular risk factors, it comes with consequences for breaking protocol and the rules. The FDA announced that the agency is "very disappointed by Orexigen's actions" and that the company will have to re-do the safety study (although Contrave still won approval since the disclosures occurred after the analysis was already finished).