Rimonabant Review

Phendimetrazine | Phentermine | Rimonabant | Xenical and Alli

Rimonabant

(Acomplia, Zimulti)

Shot down in the United States, now Sanofi-Aventis suspended European sales of Acomplia in late October, at the request of the main regulatory body in Europe. An increasing number of cases of serious psychiatric disorders, including suicide, have been reported since the drug's introduction in June 2006. Acomplia only had sales of $69 million in the first half of 2008.

Rimonabant, brand name Acomplia or Zimulti was the latest new prescription anti-obesity drug that was closest to U.S. market launch. Acomplia is a selective CB1 endocannabinoid receptor antagonist indicted for the treatment of obesity. The drug had 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 was the only endocannabinoid receptor antagonist in clinical development and this was thought to offers a unique therapeutic approach to appetite control and weight reduction. The drug also had potential as a treatment for smoking cessation.

Acomplia could 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. However, sales in that country will be suspended as well.

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. First, Rimonabant was 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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