Rimonabant Review

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Rimonabant

(Acomplia, Zimulti)

U.S. Approval In 2007 Looks Doubtful...

An FDA panel met in mid-June and unanimously rejected Acomplia (called Zimulti in the U.S.), on concerns that it increases the number of psychiatric problems such as depression and suicidal thoughts. The FDA was set to make a final decision by the end of July. With this latest action, approval in the U.S. now looks doubtful. The drug does remain approved in the European Union, though it can't be prescribed to patients suffering from depression.

The latest new prescription anti-obesity drug that was closest to U.S. market launch was Rimonabant, brand name Acomplia or Zimulti. This is a drug under development by Sanofi-Aventis (formerly Sanofi-Synthlabo). Acomplia is a selective CB1 endocannabinoid receptor antagonist indicted for the treatment of obesity. The drug has progressed to phase III development. It works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Other drug companies are developing their own compounds that work on the same brain receptors, but Sanofi-Aventis is the first to perform clinical trials

It is the only endocannabinoid receptor antagonist in clinical development and this offers a unique therapeutic approach to appetite control and weight reduction. The drug also has potential as a treatment for smoking cessation.

Acomplia, which remains a considerable distance away from approval by the FDA, has nevertheless edged a step closer to eager American customers with the news that it can now be bought in some pharmacies across the Mexican border. Mexican prices for the diet drug reportedly are in the $100 range for 28 pills, making purchases in Mexican border towns, if a visitor either lives just across the border or is in Mexico on holiday, a less expensive option than purchasing the diet pills by mail order from Europe.

The FDA has repeatedly warned that many “brand-name” drugs purchased in Mexican border pharmacies (even those in perfect packaging) have been found to be counterfeit. Surprisingly low prices for drugs should be treated with particular suspicion.

The importation of “unapproved new drugs” – any drugs that have not received FDA approval, as is the case with Acomplia, is prohibited.

Some potential medications have proved effective in the first six months of treatment only to lose effectiveness as people develop resistance to treatment. Long-term safety is a major concern. In the U.S., the FDA usually requires two years of safety data before approving anti-obesity drugs.

Side effects associated with Rimonabant in trials have included depression, anxiety and nausea. About 1 in 8 patients taking the drug dropped out of the study due to side effects, compared to 7% in the placebo group. From data that continues to accumulate, it appears that “so far so good” is the watchword. However, medical authorities urge caution and not to get too excited about it yet. First, Rimonabant is the first of a new class of drugs targeting the endocannabinoid system, which helps regulate pleasure, relaxation and pain tolerance. We still don’t have a good idea of what happens when we interfere with this system on a long-term basis.

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The information on this web site is intended for information purposes only and is not intended as a substitute for medical advice. Before starting any weight loss program, it is recommended that you consult your physician or other health care professional.

This page last updated: 2/27/2007

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