title: Challenges in the development of prescription opioid abuse-deterrent formulations.
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.
authors: Tufts University School of Medicine, Boston, MA, USA. nkatz@analgesicresearch.com
authors: Nathaniel P
authors: NP
authors: Katz
authors: Edgar H
authors: EH
authors: Adams
authors: Howard
authors: H
authors: Chilcoat
authors: Robert D
authors: RD
authors: Colucci
authors: Sandra D
authors: SD
authors: Comer
authors: Philip
authors: P
authors: Goliber
authors: Charles
authors: C
authors: Grudzinskas
authors: Donald
authors: D
authors: Jasinski
authors: Stephen D
authors: SD
authors: Lande
authors: Steven D
authors: SD
authors: Passik
authors: Sidney H
authors: SH
authors: Schnoll
authors: Edward
authors: E
authors: Sellers
authors: Debra
authors: D
authors: Travers
authors: Roger
authors: R
authors: Weiss
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000737:chemistry* / Q000191:economics; D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000191:economics; D011307:Drug Prescriptions; D006801:Humans; D007880:Legislation, Drug; D009293:Opioid-Related Disorders / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology; D011159:Population Surveillance; D012107:Research Design; D015813:Substance Abuse Detection; D009626:Terminology as Topic
chemical_list: D000701:Analgesics, Opioid