Le Foll Bernard, Gorelick David A, Goldberg Steven R
Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, University of Toronto, 33 Russell Street, M5S 2S1, Toronto, ON, Canada.
Psychopharmacology (Berl). 2009 Jul;205(1):171-4. doi: 10.1007/s00213-009-1506-7. Epub 2009 Mar 20.
Great interest has been shown by the medical community and the public in the cannabinoid CB(1) receptor antagonists, such as rimonabant, for treatment of obesity, metabolic syndrome, and possibly drug addiction.
This novel class of drug has therapeutic potential for other disorders, as the endocannabinoid system is involved in various health conditions. However, rimonabant, the first clinically available member of this class of drugs, has been linked to increased risk of anxiety, depression, and suicidality. Due to those risks, the European Medicines Agency called for its withdrawal from the market in October, 2008. Shortly after this decision, several pharmaceutical companies (Sanofi-aventis, Merck, Pfizer, Solvay) announced that they would stop further clinical research on this class of drug. Here, we provide an overview of those events and make several suggestions for continuing such clinical research, while safeguarding the safety of patients and clinical trial subjects.
医学界和公众对大麻素CB(1)受体拮抗剂(如利莫那班)用于治疗肥胖症、代谢综合征以及可能的药物成瘾表现出了极大兴趣。
这类新型药物对其他病症具有治疗潜力,因为内源性大麻素系统参与了多种健康状况。然而,这类药物中首个可用于临床的利莫那班,已被发现与焦虑、抑郁和自杀倾向风险增加有关。由于这些风险,欧洲药品管理局于2008年10月要求将其撤出市场。在这一决定做出后不久,几家制药公司(赛诺菲-安万特、默克、辉瑞、索尔维)宣布将停止对这类药物的进一步临床研究。在此,我们概述了这些事件,并就继续此类临床研究提出了一些建议,同时保障患者和临床试验受试者的安全。