Inflexxion, Inc, 320 Needham St., Newton, MA 02464, USA.
J Pain. 2013 Apr;14(4):351-8. doi: 10.1016/j.jpain.2012.08.008. Epub 2012 Nov 3.
Oxycodone hydrochloride controlled-release, also known as extended-release oxycodone (ER oxycodone), was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through nonoral routes of administration (ROAs) that require tampering (eg, injecting and snorting). Manufacturer shipments of original ER oxycodone (OC) stopped on August 5, 2010, and reformulated ER oxycodone (ORF) shipments started August 9, 2010. A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 U.S. centers between June 1, 2009, and March 31, 2012, was examined for prevalence and prescription-adjusted prevalence rates of past-30-day abuse via any route, as well as abuse through oral, nonoral, and specific ROAs for ER oxycodone and comparators (ER morphine and ER oxymorphone) before and after ORF introduction. Significant reductions occurred for 8 outcome measures of ORF versus OC historically. Abuse of ORF was 41% lower (95% CI: -44 to -37) than historical abuse for OC, with oral abuse 17% lower (95% CI: -23 to -10) and nonoral abuse 66% lower (95% CI: -69 to -63). Significant reductions were not observed for comparators. Observations were consistent with the goals of a tamper resistant formulation for an opioid. Further research is needed to determine the persistence and generalizability of these findings.
This article presents preliminary findings indicating that 8 outcome measures of abuse of a reformulated ER oxycodone were lower than that for original ER oxycodone historically, particularly through nonoral ROAs that require tampering (ie, injection, snorting, smoking), in a sentinel sample of individuals assessed for substance use problems for treatment planning.
羟考酮盐酸盐控释制剂,亦称即释羟考酮(ER 羟考酮),其配方中加入了阻止压碎和溶解的物理化学屏障,旨在通过需要篡改(例如注射和吸食)的非口服途径(ROA)来减少滥用。2010 年 8 月 5 日,原始 ER 羟考酮(OC)的制造商停止发货,2010 年 8 月 9 日开始供应改良型 ER 羟考酮(ORF)。2009 年 6 月 1 日至 2012 年 3 月 31 日期间,对美国 357 个中心的 140496 名接受药物滥用治疗评估的个体进行了哨点监测抽样,检测了所有途径、口服途径、非口服途径和特定 ROA 下过去 30 天滥用的流行率和处方调整流行率,以及 ER 羟考酮和对照药物(ER 吗啡和 ER 羟吗啡)在引入 ORF 前后的情况。与历史数据相比,ORF 有 8 个结果指标显著降低。与 OC 相比,ORF 的滥用率降低了 41%(95%CI:-44 至-37),口服滥用降低了 17%(95%CI:-23 至-10),非口服滥用降低了 66%(95%CI:-69 至-63)。对照药物未见显著减少。这些观察结果与阿片类药物防篡改配方的目标一致。需要进一步研究来确定这些发现的持久性和普遍性。
本文介绍了初步研究结果,表明改良型 ER 羟考酮的 8 项滥用结果指标均低于历史上原始 ER 羟考酮的滥用率,尤其是通过需要篡改的非口服 ROA(即注射、吸食、吸烟),这在为治疗计划评估药物使用问题的个体哨点样本中得到了证实。