Drugs R D. 2004;5(4):211-2. doi: 10.2165/00126839-200405040-00004.
Bertek Pharmaceuticals, a subsidiary of Mylan Laboratories Inc., is developing an intermittent subcutaneous formulation of apomorphine hydrochloride as a treatment for Parkinson's disease. Apomorphine injection (APO-go) for the treatment of Parkinson's disease was launched in the UK in May 2002. Bertek licensed the formulation from Britannia Pharmaceuticals in the UK for development and marketing in the US. In April 2004, apomorphine injection was approved as the first and only therapy in the US for the acute, intermittent treatment of hypomobility, 'off' episodes associated with advanced Parkinson's disease. This approval follows the fast-track status designation given by the US FDA in January 2003, and an approvable letter issued in July 2003. The product is expected to be available by July 2004.
迈兰实验室公司的子公司柏泰克制药公司正在研发一种盐酸阿扑吗啡的间歇性皮下制剂，用于治疗帕金森病。用于治疗帕金森病的阿扑吗啡注射液（APO-go）于2002年5月在英国上市。柏泰克从英国的不列颠制药公司获得该制剂的许可，在美国进行研发和销售。2004年4月，阿扑吗啡注射液被批准为美国首个也是唯一用于急性、间歇性治疗与晚期帕金森病相关的运动不能“关”期发作的疗法。该批准是在美国食品药品监督管理局于2003年1月给予快速通道地位指定以及2003年7月发出批准信之后。该产品预计将于2004年7月上市。
