Bremelanotide: First Approval
Bremelanotide: First Approval
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DOI：
10.1007/s40265-019-01187-w
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发表时间：
2019-09-01
期刊：
影响因子：
11.5
通讯作者：
Keam, Susan J.
中科院分区：
文献类型：
--
作者：
Dhillon, Sohita;Keam, Susan J.
Bremelanotide (Vyleesi (TM)) 是一种黑皮质素受体激动剂，最近在美国获批用于治疗患有获得性、全身性性欲减退症 (HSDD) 的绝经前女性，其特征是性欲低下，导致明显的痛苦或人际关系困难。这是一种自我管理的按需皮下疗法。布雷默诺肽最初由赞助 3 期临床试验的 Palatin Technologies 开发，随后被授权给 AMAG Pharmaceuticals Inc.，获得该药物在北美的独家开发和商业化权利，包括向美国 FDA 提交新药申请。 Bremelanotide 是神经肽激素 α 黑素细胞刺激激素 (α-MSH) 的合成肽类似物，与黑皮质素 4 型受体（被认为对性功能很重要）具有高亲和力，使其具有调节涉及性反应的大脑通路的潜力。本文总结了布雷默诺肽开发过程中的里程碑，从而获得了首次监管批准。
Bremelanotide (Vyleesi (TM)) is a melanocortin receptor agonist recently approved in the USA for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty. It is a self-administered, on-demand subcutaneous therapy. Initially developed by Palatin Technologies who sponsored the Phase 3 clinical trials, bremelanotide was subsequently out-licensed to AMAG Pharmaceuticals Inc. for exclusive North American rights to develop and commercialize the drug, including submitting the New Drug Application to the US FDA. Bremelanotide is a synthetic peptide analogue of the neuropeptide hormone alpha melanocyte-stimulating hormone (alpha-MSH) with high affinity for the melanocortin type 4 receptor (thought to be important for sexual function), giving it the potential to modulate brain pathways involved in sexual response. This article summarizes the milestones in the development of bremelanotide leading to this first regulatory approval.