Acomplia for smoking cessation
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Patients receiving Sanofi-Synthelabo's Acomplia (rimonabant) at 20 mg for 10 weeks "doubled the odds of quitting vs. placebo (p=0.002)," the firm announces at ACC. Prolonged abstinence was significantly higher for 20 mg vs. placebo (36.2% vs. 20.6%), but only 20.2% for 5 mg rimonabant. The double-blind, placebo-controlled study, which enrolled 787 smokers who were motivated to quit but had previously failed, is the first of three Phase III studies in the STRATUS program; a European trial is ongoing, as is a one-year maintenance study, with data expected in the next 12 months. A selective CB1 blocker, rimonabant acts on the endocannabinoid system, which regulates the body's intake of food and is involved in tobacco dependency. Acomplia is in Phase III for obesity as well...