rimonabant

(redirected from Zimulti)

rimonabant

A selective cannabinoid-1 receptor blocker that has been shown to reduce body weight and the risk of cardiovascular disease in obese people. The drug has been shown capable of achieving substantial weight loss and reducing cardiovascular risk factors. It has aroused excitement among drug manufacturers who hope it may prove effective in the control of smoking as well as excessive calorie and alcohol intake.
References in periodicals archive ?
Goodman said he could not vote for approval because of concerns about higher rates of depression, anxiety, and suicidality among Zimulti patients ("Citing Safety, FDA Panel Advises Against Zimulti Approval," July 1, 2007, p.
Sanofi Aventis, maker of Zimulti, withdrew its application for the drug after a Food and Drug Administration panel voted against recommending it for approval because of concerns about the drug's psychiatric and neurologic side effects.
application for its most-promising experimental product, the weight-loss drug Zimulti, after regulators linked it to suicide.
The company will "quickly approach the FDA in order to determine together the most suitable label for Zimulti and the activities to be performed in order to resubmit," while continuing its clinical program in rimonabant, said Marc Cluzel, Sanofi's senior vice president of scientific and medical affairs, in a conference call.
Soon after the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously against recommending approval of the weight-loss drug Zimulti, Sanofi-Aventis withdrew its new drug application, saying it needed time to discuss the panel's findings with the FDA.
The agency had been required to act on the Zimulti (rimonabant) application by July 26, and the likely result would have been a "nonapprovable" letter.
The advisory committee also expressed concerns about a high number of drop-outs in the company's four pivotal studies, and about whether Zimulti was safe for long-term use.
Goodman said that he could not vote for approval because of concerns about higher rates of depression, anxiety, and suicidality among patients treated with Zimulti.
The Food and Drug Administrations Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously against recommending approval of Sanofi-Aventis' weight-loss drug Zimulti (rimonabant).