Challenges in the development of prescription opioid abuse-deterrent formulations Journal Article
| Authors: | Katz, N. P.; Adams, E. H.; Chilcoat, H.; Colucci, R. D.; Comer, S. D.; Goliber, P.; Grudzinskas, C.; Jasinski, D.; Lande, S. D.; Passik, S. D.; Schnoll, S. H.; Sellers, E.; Travers, D.; Weiss, R. |
| Article 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. © 2007 Lippincott Williams & Wilkins, Inc. |
| Keywords: | clinical trial; review; placebo; drug efficacy; drug safety; risk benefit analysis; united states; research design; outcome assessment; animals; consensus; pain; opiate; chemistry, pharmaceutical; withdrawal syndrome; food and drug administration; drug design; cost effectiveness analysis; health care cost; prescription; reimbursement; pethidine; drug surveillance program; tramadol; toxicity testing; health care personnel; rating scale; chronic pain; drug labeling; medical liability; opioid analgesics; methadone; morphine; analgesics, opioid; opioid-related disorders; urinalysis; population surveillance; hydromorphone; cost of illness; economic aspect; analgesic agent; naloxone; drug formulation; fentanyl; oxycodone; drug misuse; opiate addiction; benzodiazepine; hydrocodone; atomoxetine; terminology; heroin dependence; substance abuse detection; abuse-deterrent; abuse-resistant; prescription opioid abuse; atropine plus diphenoxylate; dronabinol; eszopiclone; naratriptan; sufentanil; legislation, drug; prescriptions, drug |
| Journal Title: | Clinical Journal of Pain |
| Volume: | 23 |
| Issue: | 8 |
| ISSN: | 0749-8047 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2007-10-01 |
| Start Page: | 648 |
| End Page: | 660 |
| Language: | English |
| DOI: | 10.1097/AJP.0b013e318125c5e8 |
| PUBMED: | 17885342 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 46" - "Export Date: 17 November 2011" - "CODEN: CJPAE" - "Source: Scopus" |
