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Home > Archives > Vol 13, No 6 (2017)

Table of Contents

Editorial

From the editor Paul A. Sloan, MD

PDF 349

From the publisher Richard A. DeVito, Jr

PDF 350

Doctor driven problem or doctor driven solution? Lynn R. Webster, MD, FACPM, FASAM

PDF 351-352

Abuse-deterrent formulations of opioids: Many questions still to answer Raeford E. Brown Jr, MD, FAAP

PDF 353-356

Abuse-deterrent formulations approval reform: Will clinical correctness or real-world results be used to address the nation's opioid crisis: “Noninterference” as a new approval standard Dan Cohen, MA/LS

PDF 357-362

Letters to the Editor

Opioid overdose protection: An inevitable need to address an alarming epidemic Beatrice Setnik, PhD

PDF 363-364

Articles

Do abuse deterrent opioid formulations work? Richard C. Dart, MD, PhD, Janetta L. Iwanicki, MD, Nabarun Dasgupta, PhD, Theodore J. Cicero, PhD, Sidney H. Schnoll, MD, PhD

PDF 365-378

Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids Christopher J. Miller, MS, Richard C. Dart, MD, Nathaniel P. Katz, MD, MS, Lynn R. Webster, MD, FACPM, FASAM

PDF 379-389

Reality and responsibility revisited: Stakeholder accountability in the effort to develop safer opioids Steven D. Passik, PhD, Howard A. Heit, MD, Michael DeGeorge, PharmD

PDF 391-396

Opioids with abuse-deterrent properties: A regulatory and technological overview J. David Haddox, DDS, MD

PDF 397-413

Interpreting labels of abuse-deterrent opioid analgesics Lynn R. Webster, MD, FACPM, FASAM

PDF 415-423

Abuse of reformulated OxyContin: Updated findings from a sentinel surveillance sample of individuals assessed for substance use disorder Theresa A. Cassidy, MPH, Eileen Thorley, MPH, Ryan A. Black, PhD, Angela DeVeaugh-Geiss, PhD, Stephen F. Butler, PhD, Paul Coplan, ScD

PDF 425-440

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing Christopher Altomare, BS, Eric R. Kinzler, PhD, August R. Buchhalter, PhD, Edward J. Cone, PhD, Anthony Costantino, PhD

PDF 441-448

Intranasal abuse potential of an abuse-deterrent oxycodone formulation compared to oxycodone immediate release and placebo in nondependent, recreational opioid users Beatrice Setnik, PhD, Kerri Schoedel, PhD, Cindy Bartlett, MMath, Chris Dick, MS, MBA, Nasrat Hakim, MS, LLM, Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

PDF 449-464

Abuse-deterrent features of an extended-release morphine drug product developed using a novel injection-molding technology for oral drug delivery Nikolaj Skak, MS, Torben Elhauge, MSc, Jeffrey M. Dayno, MD, Karsten Lindhardt, MSc, PhD, DBE

PDF 465-472

Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations Klaus Wening, PhD, Sebastian Schwier, PhD, Hans-J. Stahlberg, MD, Eric Galia, PhD

PDF 473-484

Review Articles

Evaluating the abuse potential of opioids and abuse-deterrent opioid formulations: A review of clinical study methodology Beatrice Setnik, PhD, Kerri A. Schoedel, PhD, Naama Levy-Cooperman, PhD, Megan Shram, PhD, Glenn C. Pixton, MS, Carl L. Roland, PharmD, MS

PDF 485-523

Full Issue

Abuse Deterrent Opioids: Clinical and Public Policy Implications

PDF 341-524