Study: Experimental Obesity Drug Does Not Increase Heart Risks
Sustained-release naltrexone/bupropion set for FDA submission (November 25)
Positive cardiovascular results have been reported from a double-blind, placebo-controlled outcomes trial of the investigational obesity drug naltrexone sustained release (SR)/bupropion SR (Contrave, Orexigen Therapeutics). Based on these findings, a new drug application (NDA) will be submitted to the FDA in the next few weeks, with potential approval by June 2014.
The FDA previously agreed that if an interim analysis met the specified criteria to exclude cardiovascular risk, the obesity treatment could be approved. The prespecified criteria for the interim analysis was to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving naltrexone SR/bupropion SR compared with placebo. In addition to meeting the prespecified criteria for excluding cardiovascular risk, no new safety signals were observed.
Naltrexone SR/bupropion SR is an investigational medication being evaluated for weight loss. The drug has been shown to help people lose weight and keep it off for up to 1 year. In previous clinical trials, 53% of study participants taking naltrexone SR/bupropion SR and 21% of those taking placebo lost 5% or more of their body weight over 12 months of treatment. Those who combined naltrexone SR/bupropion SR with diet and exercise experienced the greatest reduction in body weight.
Source: Orexigen Therapeutics; November 25, 2013.