阿特维斯全球品牌药研发高副总裁Nicholson评论称，“Namzaric（之前称做MDX-8704）将两种互补性治疗药物合并在了一粒胶囊中，这两种成分通常被一起使用，大约70%的Namenda XR用药患者同时也在使用AchEI治疗药物。”

Namenda XR与AchEIs（包括多奈哌齐）的有效性与安全性在一项由677名使用稳定剂量AchEIs的医院门诊患者参与的临床试验中得到评价。两家公司指出，尽管患者未使用Namzaric治疗，但Namzaric与Namenda XR/多奈哌齐复方药物之间的生物等效性得到证实。在研究中，接受Namenda XR加一种AchEI治疗的患者与接受AchEI加安慰剂治疗的患者相比，其认知及全功能有统计学意义上的明显改善。

阿特维斯拥有这款药物在美国的独家权利，该公司指出它将于明年第二季度在美国推出两种剂量强度的Namzaric。与此同时，Adamas仍保留这款药物在美国以外市场的商业化权利。

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NAMZARIC™ is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
WARNINGS AND PRECAUTIONS
•NAMZARIC is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia
•NAMZARIC may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block
•Monitor patients for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers
•NAMZARIC can cause diarrhea, nausea, and vomiting
•NAMZARIC may cause bladder outflow obstructions
•Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine
ADVERSE REACTIONS
•The most common adverse reactions occurring at a frequency of at least 5% and greater than placebo with memantine hydrochloride extended-release 28 mg/day were headache, diarrhea, and dizziness
•The most common adverse reactions occurring at a frequency of at least 5% in patients receiving donepezil and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis
DRUG INTERACTIONS
•Combined use with NMDA antagonists: use with caution
•NAMZARIC may interfere with anticholinergic medications
•Concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists may lead to synergistic effect
DOSAGE AND ADMINISTRATION
•Patients on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg can be switched to NAMZARIC 28 mg/10 mg, taken once a day in the evening
•Severe renal impairment: patients on memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg can be switched to NAMZARIC 14 mg/10 mg
 

View the label approved on 12/23/2014 (PDF)¹¹ for NAMZARIC, NDA no. 206439