Inflexxion, Inc., Newton, Massachusetts 02464, USA.
Pain Med. 2010 Jan;11(1):81-91. doi: 10.1111/j.1526-4637.2009.00737.x. Epub 2009 Nov 25.
The present study builds on research to model abusers' perceptions of particular analgesics' attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy), Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser's point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers' overall preference for prescription opioids they had used/abused.
In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products.
Thirty-two counselors demonstrated sufficient agreement with abusers' ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R(2) of 0.15 (P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R(2) = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R(2) = 0.40; P < 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin (Purdue Pharma LP, Stamford, CT), Percocet (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin (Abbott Laboratories, Abbott Park, IL), but not Talwin NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes.
The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADFs.
本研究基于对滥用者对特定阿片类药物滥用吸引力的认知进行建模，并扩展这些方法以估计尚未上市的处方阿片类药物（镇痛新，Pain Therapeutics，Inc.，加利福尼亚州圣马特奥和 King Pharmaceuticals，Inc.，田纳西州布里斯托尔）的防滥用制剂（ADF）的滥用吸引力。在先前的研究中，阿片类药物吸引力技术标度（OATS）方法从药物滥用者的角度确定了与处方阿片类药物娱乐性使用吸引力相关的特定特征。第二项在线样本评估了这些特征在他们实际使用/滥用的特定产品中的适用程度。这些数据用于对他们实际使用/滥用的处方阿片类药物的总体偏好进行建模。
在本研究中，该方法用于一种尚未上市的 ADF，将药物滥用治疗师用作处方阿片类药物滥用者的替代品。给 38 名治疗师提供了描述新 ADF 的材料以及四种已知产品。
32 名治疗师与滥用者对这些药物总体吸引力的评分表现出足够的一致性。总体模型产生了 0.15 的显著伪 R²（P < 0.001），根据首选给药途径，模型拟合度逐渐提高，从口服（伪 R²=0.06；P < 0.001）到最适合那些喜欢注射的药物（伪 R²=0.40；P < 0.001）。16 名治疗师/代理人的交叉验证组的数据用于计算五个评定药物的 OATS 评分，结果显示新 ADF 与奥施康定（普渡制药，斯坦福德，CT）、羟考酮（Endo 制药，切兹福德，PA）和维柯丁（雅培实验室，雅培公园，IL）之间存在显著差异，但与他喷丁（Sanofi-aventis，Bridgewater，NJ）不同，在先前的研究中，他喷丁被认为是一种娱乐性使用吸引力较低的药物。
OATS 方法有望为尚未上市的 ADF 的滥用吸引力提供上市前估计。
