Whats the problem with Accomplia/rimonabant (Zimulti) the weight-loss drug that also helps you quit smoking?
Then in early 2006, the FDA did not approve rimonabant. Instead, it issued an "approvable" letter to the parent company (Sanofi-Aventis) for weight loss, and a "non-approvable" letter for smoking cessation. Undisclosed requirements were apparently placed on Sanofi before final approval for the weight loss indication is granted. Until recently everyone was very tight lipped as to what the problem was. However, on June 13th an advisory committee met to review the data on rimonabant. While they accepted the fairly good data on weight loss, they were concerned about increased rates of psychiatric symptoms and voted 14-0 not to approve the drug until there is additional data on rimonabant’s safety profile. The 20mg dose (which is most effective for weight loss) was associated with approximately double the rate of psychiatric symptoms, including suicidality.
The full FDA briefing documents for that meeting are available online at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4306b1-00-index.htm . However, it now seems fairly clear that this drug will not be approved in the U.S. in the very near future, and its next chance will be on completion of another large trial that is currently underway for weight loss. The company is adding more detailed measurement of psychiatric symptoms into the ongoing trials and will be able report on these results in a couple of years. Of course, rimonabant is the first of this new class of drugs to reach the market (at least in other countries), and the evidence of its weight loss effects (and possible effects on smoking cessation) will encourage pharma companies to develop new medicines based on similar molecules and mechanisms of action. The first of these drugs to be found effective for both weight loss and smoking cessation, (without serious side-effects) will likely be a “blockbuster” drug. In the mean time it will be interesting to hear from colleagues in Europe and South America whether this drug appears successful for weight loss and/or smoking cessation, and whether those concerning side effects are a problem in those countries.