Original ArticlesChallenges in the Development of Prescription Opioid Abuse-deterrent FormulationsKatz, Nathaniel P. MD, MS*; Adams, Edgar H. ScD†; Chilcoat, Howard ScD‡; Colucci, Robert D. PharmD§; Comer, Sandra D. PhD∥; Goliber, Philip PhD¶; Grudzinskas, Charles PhD♯; Jasinski, Donald MD**; Lande, Stephen D. PhD††; Passik, Steven D. PhD‡‡; Schnoll, Sidney H. MD, PhD§§; Sellers, Edward MD, PhD∥∥; Travers, Debra MT (ASCP)¶¶; Weiss, Roger MD♯♯Author Information *Tufts University School of Medicine †Covance, Princeton, NJ ‡GlaxoSmithKline, Research Triangle Park, NC §Colucci & Associates LLC, Newtown ∥Columbia University College of Physicians and Surgeons ¶Penwest Pharmaceuticals Co, Danbury, CT ♯NDA Partners LLC, Annapolis **Johns Hopkins Bayview Medical Center, Baltimore ††Interactive Forums, Inc, Bala Cynwyd ‡‡Memorial Sloan Kettering Cancer Center, New York, NY §§Pinney Associates, Bethesda, MD ∥∥Ventana Clinical Research Corporation, and University of Toronto, Toronto, Canada ¶¶Endo Pharmaceuticals, Chadds Ford, PA ♯♯Harvard Medical School, Boston, MA Sources of financial support: Abbott Laboratories; Alpharma; ALZA Corporation; Cephalon, Inc; Grunenthal GmbH; Johnson & Johnson Pharmaceutical Services; Ligand Pharmaceuticals, Inc; New River Pharmaceuticals Inc; Purdue Pharma LP; QrxPharma Pty Ltd. Disclaimer: The views expressed in this paper are those of the authors. No official endorsement by the US Food and Drug Administration or other institutions mentioned above, or any of the supporting pharmaceutical companies, should be inferred. Reprints: Nathaniel P. Katz, MD, MS, Analgesic Research, 109 Highland Avenue, Needham, MA 02494 (e-mail: [email protected]). Received for publication November 10, 2006; accepted May 24, 2007 The Clinical Journal of Pain: October 2007 - Volume 23 - Issue 8 - p 648-660 doi: 10.1097/AJP.0b013e318125c5e8 Buy Metrics Abstract Opioid analgesics remain the cornerstone of effective management for moderate-to-severe pain. In the face of persistent lack of access to opioids by patients with legitimate pain problems, the rate of prescription opioid abuse in the United States has escalated over the past 15 years. Abuse-deterrent opioid products can play a central role in optimizing the risk-benefit ratio of opioid analgesics—if these products can be developed cost-effectively without compromising efficacy or creating new safety issues for the target treatment population. The development of scientific methods for assessing prescription opioid abuse potential remains a critical and challenging step in determining whether a claim of abuse deterrence for a new opioid product is indeed valid and will thus be accepted by the medical, regulatory, and reimbursement communities. To explore this and other potential impediments to the development of prescription opioid abuse-deterrent formulations, a panel of experts on opioid abuse and diversion from academia, industry, and governmental agencies participated in a Tufts Health Care Institute-supported symposium held on October 27 and 28, 2005, in Boston, MA. This manuscript captures the main consensus opinions of those experts, and also information gleaned from a review of the relevant published literature, to identify major impediments to the development of opioid abuse-deterrent formulations and offer strategies that may accelerate their commercialization. © 2007 Lippincott Williams & Wilkins, Inc.