Kilpatrick Gavin J, Tilbrook Gary S
CeNeS Ltd, Compass House, Vision Park, Histon, Cambridge, UK.
Curr Opin Investig Drugs. 2002 May;3(5):798-806.
Memantine hydrochloride, an NMDA antagonist, was launched in Germany by Merz in 1989 for the treatment of dementia, an indication for which development was continuing in other markets. It is also under development by Merz, Lundbeck, Neurobiological Technologies Inc (NTI) Forest Laboratories and Suntory for the potential treatment of Alzheimer's disease (AD), AIDS-related dementia and pain in patients with neuropathy, and by Allergan for the potential treatment of ocular disease. By July 2001, a regulatory filing for neuropathic pain was expected in 2003. In February 2002, the CPMP recommended to the EU commission to approve memantine for the treatment of moderately severe-to-severe Alzheimer's disease. At this time, marketing authorization was expected late in the first half of 2002, and Lundbeck planned to launch memantine under the brand name Ebixa during the second half of 2002. Merz and Lundbeck, filed memantine for AD in the EU in September 2000 and an NDA was submitted in November of that year. The compound was in phase H trials in the US for the treatment of AIDS-related dementia and pain by August 1996 and phase III trials for glaucoma and neuroprotection by 1999. Analysts at Merrill Lynch predicted in October 2001 that Allergan would make regulatory filings in the US for memantine in glaucoma and ocular hypertension in 2005, and that Forest Laboratories would file for memantine in the US as a supplement to Alzheimer's disease data in early 2002, and for the treatment of neuropathic pain in 2003. Sales of $25 million in 2004, rising to $75 million in 2005, were predicted by Merrill Lynch for this product.
盐酸美金刚是一种N-甲基-D-天冬氨酸（NMDA）拮抗剂，1989年由默茨公司在德国推出用于治疗痴呆症，当时其他市场仍在对该适应症进行研发。默茨公司、灵北公司、神经生物技术公司（NTI）、福瑞斯特实验室和三得利公司也在对其进行研发，用于潜在治疗阿尔茨海默病（AD）、艾滋病相关痴呆症以及神经病变患者的疼痛；艾尔建公司则在对其进行研发，用于潜在治疗眼部疾病。到2001年7月，预计2003年将提交关于神经性疼痛的监管申请。2002年2月，人用药品委员会（CPMP）建议欧盟委员会批准美金刚用于治疗中度至重度阿尔茨海默病。此时，预计2002年上半年晚些时候会获得上市许可，灵北公司计划于2002年下半年以Ebixa为品牌推出美金刚。默茨公司和灵北公司于2000年9月在欧盟提交了美金刚用于治疗AD的申请，并于当年11月提交了新药申请（NDA）。截至1996年8月，该化合物在美国处于治疗艾滋病相关痴呆症和疼痛的II期试验阶段，到1999年处于治疗青光眼和神经保护的III期试验阶段。美林证券的分析师在2001年10月预测，艾尔建公司将于2005年在美国提交美金刚用于治疗青光眼和高眼压症的监管申请，福瑞斯特实验室将于2002年初在美国提交美金刚作为阿尔茨海默病数据补充的申请，并于2003年提交用于治疗神经性疼痛的申请。美林证券预测该产品2004年销售额为2500万美元，2005年将增至7500万美元。
