Acomplia (rimonabant)

On March 9, 2004 Sanofi-Synthelabo announced preliminary Phase III results for Acomplia™ (rimonabant), in two clinical trials: the Stratus-US (smoking cessation) trial and the RIO-Lipids/weight loss (obesity) trial. The Stratus-US trial randomized 787 smokers who wanted to quit to use either a placebo, a 5-milligram daily dose of Acomplia or a 20-milligram daily dose, in addition to brief weekly counseling. The study’s subjects were smokers for at least two months, and had smoked at least 10 cigarettes a day. After 10 weeks, 36% of subjects on the higher dose of Acomplia had quit smoking, a rate 2.2 times higher than for subjects given a placebo. In addition, subjects on the higher dose showed 77% less weight gain than the ones treated with a lower dose or a placebo. The RIO-Lipids trial, a double-blind, placebo- controlled study, enrolled 1,036 overweight or obese patients with dyslipidemia (high triglycerides and/or high total cholesterol/HDL cholesterol ratio) and a Body Mass Index (BMI) between 27 and 40 kg/m2. Patients were randomized to receive either a daily, fixed dose of Acomplia (5 mg or 20 mg) or placebo along with a reduced calorie diet for one year. Patients treated for one year with Acomplia 20 mg per day lost 8.6 kg (almost 20 lbs) vs. a loss of only 2.3 kg (5 lbs) on placebo (p<0.001). Nearly 75% (p<0.001 vs. placebo) of patients treated for one year with Acomplia 20 mg lost over 5% of their body weight as compared to 41.8% (p = 0.002 vs. placebo) of patients on Acomplia 5 mg and 27.6% of patients in the placebo group. In addition to weight loss, RIO-Lipids was designed to assess a number of important associated cardiovascular risk factors. All improvements in risk factors were statistically significant vs. the control group.

In 1999–2000, an estimated 30% of U.S adults aged 20 years and older, nearly 59 million people, were obese, defined as having a body mass index (BMI) of 30 or more. An estimated 71.5 million Americans reported current use (past month use) of a tobacco product in 2002, a prevalence rate of 30.4 percent for the population aged 12 or older.

Rimonabant is a selective cannabinoid type 1 (CB-1) receptor blocker. Endocannabinoids are naturally occurring substances in the brain and other areas of the body that play a role in controlling a number of physiologic activities, including food intake and energy balance. They also regulate the reinforcing effect of nicotine.

We continue to monitor Sanofi’s plans for Acomplia’s FDA submission. Pending further information, we do not recommend preliminary assessment activities at this time.

Technology Details
Target Disease / Indication
Smoking Cessation/Obesity

Technology Classification
Drug

Body System
Multiple Systems

Program Area
Medicine

Regulatory Status
Phase III

BioHorizon Impact Score
75/100 – High