Orexigen Submits Weight Management Drug Contrave in Europe
On October 3, Orexigen announced that it submitted Contrave (naltrexone/bupropion) to the European Medicine Agency for weight loss management. Assuming a successful review, Contrave could be available in Europe by the end of 2014. The company also indicated that it is planning to resubmit Contrave to the FDA by the end of 2013.
In previous trials, participants using Contrave averaged about 5% greater weight loss over a year than those using a placebo (a pill with no medication), and participants who completed the trial averaged 8-11.5% weight loss depending on their diet. People taking Contrave experienced slight increases in heart rate and blood pressure when compared to placebo, and concerns over these cardiovascular side effects led the FDA to delay approval for Contrave in 2011 while it awaited more data (that has now been shared). Orexigen is currently conducting a cardiovascular outcomes study with about 9,000 patients to assess if there is any increased risk of cardiovascular events (e.g., stroke, heart attack, death from cardiovascular causes) associated with Contrave. To learn more about the study, please read our new now next here.
If approved, Contrave would be the third obesity medication that would become available in the US, following a 13-year period of no FDA approvals of obesity drugs. Arena/Eisai’s weight management drug Belviq launched in the US in June 2013 and Vivus’ obesity drug Qsymia launched in September 2013. We have been extremely impressed with recent obesity medicines in terms of their impact on diabetes and reduction in A1c associated with taking the drug. Qsymia has had some real improvements on the reimbursement side and it is now fairly easy for people to try Qsymia for several months at a very minimal cost (learn more here). –NL/HD