Seventeen years since rimonabant's downfall: reassessing its suicidality risk profile

IF 4.2 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM Obesity Pub Date : 2024-06-17 DOI:10.1002/oby.24019
Yuval Cohen, Andrew Kolodziej, Marshall Morningstar
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Abstract

Targeting the cannabinoid type 1 receptor (CB1) is a clinically validated antiobesity therapeutic approach. The only such drug approved, rimonabant, was launched in 2006 in Europe but subsequently rejected by the US Food and Drug Administration (FDA) in 2007. The FDA cited the increased risk of suicidality in its opposition to rimonabant's approval, leading to the drug's eventual worldwide withdrawal and the abandonment of this class of therapeutics. Seventeen years later, a new class of CB1-targeting drugs is emerging, but the impact of the 2007 FDA decision remains a formidable obstacle to its clinical development. We revisit the suicidality data presented by the FDA in light of the evolution of suicidality assessment and cross-reference this with the data in the subsequently published clinical trials. We conclude that the publicly available data do not support the FDA's conclusion that the use of rimonabant was associated with an increase in the risk of suicidality.

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利莫那班垮台十七年:重新评估其自杀风险。
以大麻素 1 型受体(CB1)为靶点是一种经过临床验证的抗肥胖治疗方法。唯一获得批准的此类药物利莫那班于 2006 年在欧洲上市,但随后于 2007 年被美国食品药品管理局(FDA)否决。美国食品和药物管理局以增加自杀风险为由反对批准利莫那班,导致该药物最终在全球范围内撤出,这一类治疗药物也被放弃。17 年后的今天,一类新的 CB1 靶向药物正在崛起,但 2007 年 FDA 决定的影响仍然是其临床开发的巨大障碍。我们根据自杀性评估的演变重新审视了 FDA 提供的自杀性数据,并将其与随后公布的临床试验数据进行了交叉对比。我们的结论是,公开的数据并不支持 FDA 关于使用利莫那班会增加自杀风险的结论。
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来源期刊
Obesity
Obesity 医学-内分泌学与代谢
CiteScore
11.70
自引率
1.40%
发文量
261
审稿时长
2-4 weeks
期刊介绍: Obesity is the official journal of The Obesity Society and is the premier source of information for increasing knowledge, fostering translational research from basic to population science, and promoting better treatment for people with obesity. Obesity publishes important peer-reviewed research and cutting-edge reviews, commentaries, and public health and medical developments.
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