King Pharmaceuticals, Inc., Cary, NC, USA.
Pain Med. 2011 Apr;12(4):618-31. doi: 10.1111/j.1526-4637.2011.01093.x. Epub 2011 Apr 4.
Remoxy(®) is a water-insoluble, highly viscous oral formulation of oxycodone extended release (ER) currently in development. The primary objective was to determine the abuse potential of Remoxy under fed conditions relative to oxycodone ER and immediate release (IR) under fasted conditions and compared with placebo (treatment group X). A secondary objective was to evaluate abuse potential under reversed fed/fasted conditions (treatment group Y).
Phase I randomized double-blind triple-dummy placebo- and active-controlled 6-way crossover study. Setting. A single US site. PATIENTS. Healthy men and women aged 18-50 years who were nondependent, recreational opioid users. Interventions. Remoxy 40 mg whole and chewed, oxycodone ER 40 mg whole and crushed, oxycodone IR 40 mg crushed, and placebo.
The primary endpoint was the drug liking subscale of the drug effects questionnaire assessed by various pharmacodynamic parameters. Secondary endpoints included additional pharmacodynamic measures, chewing duration, and safety measures.
In treatment group X, Remoxy whole (fed) and chewed (fed) had a significantly lower abuse potential compared with oxycodone ER (crushed, fasted) and IR (fasted) based on the majority of pharmacodynamic parameters of interest for the primary endpoint (drug liking subscale) as well as secondary endpoints. Treatment group Y showed generally similar results.
The abuse potential of Remoxy when taken whole or chewed was significantly lower than two comparators with known abuse potential, including oxycodone IR and crushed oxycodone ER, under the fed/fasted conditions tested. Remoxy may be associated with a reduced risk potential for abuse.
Remoxy（®）是一种正在开发的水溶性差、高度粘稠的羟考酮缓释（ER）口服制剂。主要目的是确定 Remoxy 在进食条件下相对于禁食条件下的羟考酮 ER 和即时释放（IR）以及与安慰剂（治疗组 X）相比的滥用潜力。次要目的是评估在相反的进食/禁食条件下（治疗组 Y）的滥用潜力。
一项在单中心进行的、随机、双盲、三模拟、安慰剂和活性对照的 6 向交叉研究。
一个单一的美国站点。
年龄在 18-50 岁之间的健康男性和女性，他们是非依赖性的、娱乐性阿片类药物使用者。
Remoxy 40mg 整片和咀嚼、羟考酮 ER 40mg 整片和粉碎、羟考酮 IR 40mg 粉碎和安慰剂。
主要终点是通过各种药效学参数评估药物效应问卷的药物喜好子量表。次要终点包括其他药效学测量、咀嚼持续时间和安全性测量。
在治疗组 X 中，Remoxy 整片（进食）和咀嚼（进食）与羟考酮 ER（粉碎、禁食）和 IR（禁食）相比，具有明显较低的滥用潜力，这基于主要终点（药物喜好子量表）和次要终点的大多数药效学参数。治疗组 Y 显示出类似的结果。
在测试的进食/禁食条件下，Remoxy 整片或咀嚼的滥用潜力明显低于两种已知有滥用潜力的对照药物，包括羟考酮 IR 和粉碎的羟考酮 ER。Remoxy 可能与降低滥用风险有关。
