森林实验室（Forest Lab）和合作伙伴Adamas制药公司3月4日宣布，已向FDA提交了缓释美金刚（memantine ER）+多奈哌齐（donepezil）固定剂量组合产品（FDC）的新药申请（NDA），该药开发用于中度至重度阿尔茨海默型老年痴呆症（Alzheimer's type dementia）的治疗。
美金刚（memantine）和多奈哌齐（donepezil）联合用药，是用于阿尔茨海默氏症患者中度至重度老年痴呆症的一套行之有效的治疗方案。缓释美金刚ER/多奈哌齐FDC，有助于帮助减轻患者日常用药的负担，并改善患者的依从性和合规（compliance，即遵医行为）。
美金刚ER/多奈哌齐FDC是一种每日一次的口服胶囊，适用于目前正在服用美金刚（10mg每日2次，或28mg缓释）和多奈哌齐（10mg）的患者。此外，该胶囊可以被打开，并允许撒在苹果酱中，以方便可能有吞咽困难的患者。
美金刚ER/多奈哌齐FDC的新药申请包括2种给药剂量，28mg/10mg和14mg/10mg，后者可用于有严重肾功能损害的患者。
目前，美金刚缓释（memantine ER）胶囊已以品牌名NAMENDA XR上市销售，适用于中度至重度阿尔茨海默型老年痴呆的治疗。多奈哌齐品牌名为ARICEPT，适用于轻度至重度阿尔茨海默型老年痴呆的治疗。
上个月，Forest lab与全球第三大仿制药商阿特维斯（Actavis）签订了一份收购协议，交易总额达250亿美元（约每股89.48美元），今日，Forest lab股价收于99.36美元。
通过此次收购，Actavis将获得阿尔茨海默氏症药物Namenda及一些新药如抗抑郁药物Viibryd。分析师称，此次收购将赋予Actavis更多的话语权，与医院和其他医疗护理提供商进行谈判。
NEW YORK & EMERYVILLE, Calif.--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX), a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, and Adamas Pharmaceuticals Inc., a privately held specialty pharmaceutical company, announced Forest’s submission of a New Drug Application (NDA) to the Food and Drug Administration for a fixed-dose combination (FDC) of memantine HCl extended release (ER) and donepezil HCl for the treatment of moderate to severe dementia of the Alzheimer’s type.
“The concurrent use of memantine and donepezil is a well-established treatment option for patients with moderate to severe dementia related to Alzheimer’s disease. Using the two drugs together appears to provide benefit over using acetylcholinesterase inhibitors alone. Reducing the number of pills by offering patients a fixed-dose combination helps lessen the daily medication burden and could improve patient adherence and compliance,” said Pierre Tariot, MD, at the Banner Alzheimer’s Institute, who has also consulted to both Adamas and Forest.
The memantine ER-donepezil HCl FDC is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on applesauce to facilitate dosing for patients who may have difficulty swallowing.
The New Drug Application consisted of two dosage strengths, 28mg/10mg (memantine extended release/donepezil) and 14mg/10mg (memantine extended release/donepezil) for patients with severe renal impairment. Memantine ER is the active ingredient in the currently marketed NAMENDA XR?, which is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Donepezil is the active ingredient in ARICEPT?, which is indicated for the treatment of mild to severe dementia of the Alzheimer’s type. Forest and Adamas collaborated on the development of the fixed dose combination and Forest will have exclusive US commercialization rights while Adamas will retain exclusive commercialization rights outside of the US. The FDC product is covered by multiple Adamas patents and a Forest patent that extend to 2029.
About Alzheimer’s disease
Alzheimer’s disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks. An estimated 5.2 million people in the United States are currently living with Alzheimer’s disease. Alzheimer’s disease is the fifth leading cause of death in the United States among those aged 65 and older, and was reported as an underlying cause of death for more than 83,000 Americans in 2010.
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