After a four-month dry spell during which there has been little news about development of the highly publicized obesity drug Acomplia (rimonabant), researchers are scheduled to present new data from the RIO-Europe clinical trial at a scientific meeting in Orlando on Tuesday, March 8th.

The presentation of the first two-year results from the RIO-Europe study will take place at a special session devoted to late-breaking clinical trial results at the American College of Cardiology's annual scientific meeting in Orlando.

The update will be presented by Dr. Luc Van Gaal, professor of Diabetology, Metabolism and Clinical Nutrition at Belgium's University Hospital Antwerp, who has been the principal researcher on the RIO-Europe clinical trial.

A commentary on the update will then be presented by Dr. Julius M. Gardin, chief of cardiology at St. John Hospital & Medical Center in Detroit.

Sanofi Aventis, developer of the drug, reiterated today (March 1) that it intends to file in the second quarter of this year for U.S. approval to sell Acomplia.

Hanspeter Spek, head of pharmaceutical operations, told reporters and analysts he was hopeful of winning a fast-track review from the U.S. Food and Drug Administration, clearing the way for the drug to reach the market at the end of 2005 or early in 2006.

First-year results from the RIO-Europe study fueled excitement over the potential of this new type of obesity drug when they were presented last August at the European Society of Cardiology (ESC) 2004 Congress.

The enthusiasm over this drug then surged in November, when two-year findings from the RIO-North America trial showed that Acomplia helped obese and overweight people lose significantly more weight -- and keep the weight off -- than a placebo.

With Sanofi nearing a filing for initial regulatory approvals to sell Acomplia, obesity experts are eagerly awaiting two-year results from the RIO-Europe trial for two reasons:

• To see if the RIO-Europe trial continues to support the highly encouraging two-year findings from the RIO-North America trial.
• To see if the RIO-Europe trial supports Sanofi's contention that side-effects from prolonged use of Acomplia do not appear to be a major issue.

Sanofi officials also seem certain to be questioned at the Orlando meeting about long-term data from its STRATUS trials, in which Acomplia is being evaluated for use in helping smokers break the habit.