Health
FDA issues approvable letter for weight-loss drug
NEWS IN BRIEF — Posted March 13, 2006
The Food and Drug Administration has issued a letter to Sanofi-Aventis stating that rimonabant is approvable for weight loss but not approvable for smoking cessation, according to a February statement by the company.
The drug is the first of the new selective cannabinoid-1 receptor blocker class of medications. Generally positive results from trials looking at its effectiveness have trickled out over the past couple years. Most recently, the Feb. 15 Journal of the American Medical Association published results from the large-scale RIO-North America trial.
More than 3,000 obese patients received either placebo or various doses of the drug over two years. Those who took 20 mg and dieted lost approximately five kilograms more than those who took the placebo. Triglycerides and high-density cholesterol also declined more significantly in the group that received the drug.
Researchers concluded that the drug was effective but expressed concern because the dropout rate for all arms of the trial hovered around 50%.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/03/13/hlbf0313.htm.
