Monck Nat
Vernalis Research Ltd, Winnersh, Wokingham, UK.
Curr Opin Investig Drugs. 2002 Mar;3(3):459-62.
Endo (which acquired Algos in July 2000) has developed EN-3231, a combination of morphine and dextromethorphan, for the treatment of moderate-to-severe chronic pain. In October 1998, the FDA accepted for filing the company's NDA submission on EN-3231, which was submitted in August 1998. However, in August 1999, Algos received a 'non-approvable' letter from the FDA for EN-3231. In September 2000, the company met with the FDA to discuss what information the FDA required in order to approve EN-3231. The FDA requested a second pivotal trial, which Endo initiated promptly. Endo hoped to file its supplement to the NDA during 2002.
恩多公司（于2000年7月收购了阿尔戈斯公司）研发了EN - 3231，这是一种吗啡和右美沙芬的复方制剂，用于治疗中重度慢性疼痛。1998年10月，美国食品药品监督管理局（FDA）接受了该公司于1998年8月提交的关于EN - 3231的新药申请（NDA）存档。然而，1999年8月，阿尔戈斯公司收到了FDA关于EN - 3231的“不予批准”函。2000年9月，该公司与FDA会面，讨论FDA为批准EN - 3231所需的信息。FDA要求进行第二项关键试验，恩多公司迅速启动了该试验。恩多公司希望在2002年期间提交NDA补充申请。
