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rimonabant : ウィキペディア英語版
rimonabant

Rimonabant (also known as SR141716; trade name Acomplia) is an anorectic antiobesity drug that has been withdrawn from the market due to potentially serious side effects. It was approved for use in Europe and other countries, but never approved in the United States. Rimonabant is an inverse agonist for the cannabinoid receptor CB1. It has also been shown to be a μ-opioid receptor antagonist (possibly the contributing factor in its reported dysphoric qualities).〔(AM-251 and rimonabant act as direct antagonists at mu-opioid receptors: implications for opioid/cannabinoid interaction studies. ) Neuropharmacology. 2012 Oct;63(5):905-15. doi: 10.1016/j.neuropharm.2012.06.046. Epub 2012 Jul 4. PMID 22771770 PMCID: PMC3408547〕 Its main effect is reduction in appetite.
==History==

Rimonabant was the first selective CB1 receptor blocker to be approved for use anywhere in the world. In Europe, it was indicated for use in conjunction with diet and exercise for patients with a body mass index (BMI) greater than 30 kg/m², or patients with a BMI greater than 27 kg/m² with associated risk factors, such as type 2 diabetes or dyslipidaemia. In the UK, it was available beginning in July 2006. As of 2008, the drug was available in 56 countries.
On 21 June 2006, the European Commission approved the sale of rimonabant in the then-25-member European Union. Pharmaceutical company Sanofi-Aventis, (which changed its name to Sanofi in 2011) announced the first country in which Acomplia would be sold was the United Kingdom as a prescription drug. Sales began in July 2006. Sanofi-Aventis also projected that the drug would be sold shortly thereafter in Denmark, Ireland, Germany, Finland, and Norway. It was expected in Belgium and Sweden in 2007. Ordinary obesity would, according to official medical recommendations, not be enough to acquire the prescription in Sweden; there would be additional requirements concerning abnormal blood lipid levels.〔 〕
Rimonabant was submitted to the Food and Drug Administration (FDA) for approval in the United States. However, in 2007, the FDA's Endocrine and Metabolic Drugs Advisory Committee (EMDAC) concluded the French manufacturer Sanofi-Aventis failed to demonstrate the safety of rimonabant and voted against recommending the anti-obesity treatment for approval. Subsequently, Sanofi-Aventis announced it was suspending the new drug application (NDA) for rimonabant, and that it would resubmit an application at some point in the future.
The EU's approval was not a blanket approval, nor did it approve Acomplia for nonobesity-related problems, such as smoking cessation, although off-label use of the drug was still possible. The approval was, in combination with diet and exercise, for the treatment of obese patients (BMI greater than or equal to 30), or overweight patients (BMI greater than 27) with associated risk factors, such as type 2 diabetes or dyslipidaemia.
In October 2008, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had determined that the risks of Acomplia outweighed its benefits. The Agency subsequently recommended that the product be suspended from the UK market, and that doctors not prescribe the drug due to the risk of serious psychiatric problems, and even suicide. Sanofi-Aventis then suspended sale of the drug. Approval of the drug was officially withdrawn by the European Medicines Agency on 16 January 2009.
India has prohibited the manufacture and sale of the drug.〔(【引用サイトリンク】title=Drugs banned in India )

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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