DOC News July 1, 2004
Volume 1 Number 1 p. 13
© 2004 American Diabetes Association
CLINICAL TRIAL SHOWS EFFICACY OF "ANTI-MUNCHIE" DRUG
A Phase III multicenter clinical trial demonstrates that a new class of
drug—a selective endocannabinoid receptor antagonist (CB1)—may be
an effective treatment for obesity, according to a report at the recent
Endocrine Society annual meeting in New Orleans.
Rimonabant, under development by Sanofi-Synthelabo, blocks receptors in the
hypothalamus that bind with cannabinoid molecules contained in marijuana that
stimulate appetite, commonly known as "the munchies." Blocking the
CB1 receptor appears to curb the craving for food and also for cigarettes.
Rimonabant, under the brand name Accomplia, is being developed as a treatment
for obesity and smoking cessation.
In a multicenter trial, 287 male and female subjects 18 to 65 years old
with a body mass index (BMI) of 29 to 41 were randomized to receive 5, 10, or
20 mg of rimonabant or placebo while on a slightly hypocaloric diet. After 16
weeks, patients receiving the drug lost an average of two to four times more
weight (5 to 8 lb.) than patients on placebo. In addition, the waist
circumference among patients taking rimonabant decreased more than twice as
much as those on placebo. No serious adverse effects were reported, according
to principal investigator Xavier Pi-Sunyer, MD, director of the Obesity
Research Center at St. Luke's Hospital Center in New York City.
Rimonabant has been tested in Phase III clinical trials involving more than
6,000 obese subjects in the United States and Europe.
Now that it has passed two clinical trials, rimonabant appears headed for
review by the Food and Drug Administration. As long-term safety and efficacy
are major concerns, the agency typically requires 2 years of data before
approving obesity drugs. A New Drug Application for rimonabant could be filed
within a year or two.
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