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.
摘要：
靶向大麻素1型受体（CB1）是一种临床验证的抗肥胖治疗方法。唯一被批准的这种药物，利莫那班,于2006年在欧洲推出，但随后于2007年被美国食品和药物管理局（FDA）拒绝。FDA在反对利莫那班的批准时提到自杀风险增加，导致该药物最终在全球范围内停药，并放弃了这类疗法。十七年后,一类新的CB1靶向药物正在出现，但是2007年FDA决定的影响仍然是其临床开发的巨大障碍。我们根据自杀评估的演变，重新审视FDA提供的自杀数据，并将其与随后发表的临床试验中的数据进行交叉引用。我们得出的结论是，公开数据不支持FDA的结论，即使用利莫那班与自杀风险增加有关。
