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盐酸苯丁胺和托吡酯缓释片(Qsymia™):全球首次批准。

Phentermine and topiramate extended release (Qsymia™): first global approval.

机构信息

Adis R&D Insight, Springer Healthcare, Auckland, New Zealand.

出版信息

Drugs. 2012 Oct 22;72(15):2033-42. doi: 10.2165/11640860-000000000-00000.

DOI:10.2165/11640860-000000000-00000
PMID:23039320
Abstract

Vivus' proprietary oral capsule containing phentermine and extended-release (ER) topiramate has been approved in the US for the treatment of obesity. Phentermine is an appetite suppressant, while topiramate is an anti-epileptic medication. The once-daily formulation, known as Qsymia™, is designed to produce weight loss by decreasing appetite and increasing satiety. The product is also in clinical development for sleep apnoea syndrome and type 2 diabetes mellitus. This article summarizes the milestones in the development of phentermine/topiramate ER leading to this first approval for obesity.

摘要

维梧制药公司拥有的含有苯丁胺和缓释托吡酯的口服胶囊已在美国获准用于肥胖症的治疗。苯丁胺是一种食欲抑制剂,而托吡酯是一种抗癫痫药物。这种每日一次的配方药名为 Qsymia™,旨在通过降低食欲和增加饱腹感来达到减肥的效果。该产品也正在开发用于治疗睡眠呼吸暂停综合征和 2 型糖尿病。本文总结了导致苯丁胺/托吡酯 ER 首次获批肥胖症的关键研发里程碑。

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Anti-obesity drugs: past, present and future.抗肥胖药物:过去、现在和未来。
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Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.低剂量、控释型、苯丁胺与托吡酯复方制剂对超重和肥胖成年人体重及相关合并症的影响(CONQUER):一项随机、安慰剂对照、3 期临床试验。
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