Opioid formulations in development designed to curtail abuse: Who is the target?

Expert Opinion on Investigational Drugs

Volumn 18, Issue 3, 2009, Pages 255-263

  Webster, Lynn R ^a   Bath, Brad ^a   Medve, Robert A ^a  

^a Lifetree Clinical Research and Pain Clinic   (United States)

Author keywords

Abuse addiction; Abuse deterrent; Abuse resistant; Chronic pain; Diversion; Opioids; Sequestered antagonist; Tamper

Indexed keywords

ANALGESIC AGENT; COL 003; DRUG ADDITIVE; HYDROMORPHONE; JURNISTA; MORPHINE; NALTREXONE; NALTREXONE PLUS OXYCODONE; NIACIN PLUS OXYCODONE; NICOTINIC ACID; OPIATE; OPIATE ANTAGONIST; OXYCODONE; PLACEBO; TQ 1017; TRAMADOL; UNCLASSIFIED DRUG; NARCOTIC ANALGESIC AGENT;

ANALGESIA; CHRONIC PAIN; CONTROLLED RELEASE FORMULATION; CORRELATION ANALYSIS; DIZZINESS; DRUG ABUSE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG MISUSE; DRUG MIXTURE; DRUG SAFETY; DRUG WITHDRAWAL; FLUSHING; FOOD AND DRUG ADMINISTRATION; HEAT; HUMAN; IMMEDIATE DRUG RELEASE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORTH AMERICA; NOSE IRRITATION; OSTEOARTHRITIS; PAIN; PRURITUS; REVIEW; REWARD; SIDE EFFECT; SUSTAINED DRUG RELEASE; SWEATING; TECHNOLOGY; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; VOMITING; ADDICTION; ANIMAL; CHEMISTRY; DRUG DESIGN;

ANALGESICS, OPIOID; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DRUG DESIGN; HUMANS; SUBSTANCE-RELATED DISORDERS;

EID: 67449100590     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543780902751622     Document Type: Review

References (33)

1. Wood GB, Bache F. The dispensatory of the United States of America. Eleventh edition. Philadelphia, PA: J.B. Lippincott and Co.; 1858. p. 551-565
2. Mahowald ML, Singh JA, Majeski P. Opioid use by patients in an orthopedics spine clinic. Arthritis Rheum 2005;52(1):312-321 (Pubitemid 40129264)
3. Kalso E, Simpson KH, Slappendel R, et al. Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine. BMC Med 2007;5:39 (Pubitemid 351266930)
4. Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004;112(3):372-380 (Pubitemid 39550738)
5. Noble M, Tregear SJ, Treadwell JR, Schoelles K. Long-term opioid therapy for chronic noncancer pain: a systematic review and meta-analysis of efficacy and safety. J Pain Symptom Manage 2008;35(2):214-228
6. Substance Abuse and Mental Health Services Administration. Results from the 2007 national survey on drug use and health: national findings. NSDUH Series H-34, DHHS Publication No. SMA 08-4343. Rockville, MD: Office of Applied Studies; 2008
7. Butler SF, Benoit C, Budman SH, et al. Development and validation of an opioid attractiveness scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J 2006;3:5 (Pubitemid 43299050)
8. Hays LR. A profile of OxyContin addiction. J Addict Dis 2004;23(4):1-9 (Pubitemid 39390624)
9. McCabe SE, Cranford JA, Boyd CJ, Teter CJ. Motives, diversion and routes of administration associated with nonmedical use of prescription opioids. Addict Behav 2007;32(3):562-575 (Pubitemid 46038570)
10. Webster LR, Butera PG, Moran LV, et al. Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 2006;7(12):937-946 (Pubitemid 44854737)
11. Alpharma announces the resubmission of a New Drug Application for EMBEDA™ Capsules [press release]. Bridgewater, NJ: Alpharma, June 30, 2008. Available from: http://www.alpharma.com/pages/getpage. aspx?id = 65a2358b-5aeb-4c98-b468- 4232637d493b. [Accessed 23, October 2008 ]
12. Rittenhouse PA, Usdin S. Regulation: painfully short of answers. BioCentury 2008;16(51):A1-6
13. Alpharma's Phase III pivotal clinical placebo-controlled trial of its abuse-deterrent, extended release opioid demonstrates significant efficacy [press release]. Bridgewater, NJ: Alpharma; November 29, 2007. Available from: http://www.alpharma.com/pages/getpage.aspx?id=5ee99c4b-abba-4e79-9e5f- a935bfa1b6f7. [Accessed 23, October 2008 ]
14. Jones J, Johnson F, Wagner G, et al. Evaluation of abuse potential of ALO-01, an extended-release morphine sulfate plus sequestered naltrexone formulation, among recreational opioid users. J Pain 2008;9(4):34 . No.235
15. Acurox™ tablets meet primary endpoint in pivotal Phase III study: Opioid with a unique composition of ingredients intended to deter common methods of prescription drug abuse [press release]. Palatine, Il, and Bristol, TN: Acura Pharmaceuticals, Inc., and King Pharmaceuticals, Inc., June 17, 2008. Available from: http://www.acurapharm.com/Press%20Releases/pr06172008.htm. [Accessed 23, October 2008]
16. Acura Pharmaceuticals and King Pharmaceuticals announce positive top line results of key clinical study assessing abuse liability: Acurox™ tablets significantly disliked when excess doses are swallowed [press release]. Palatine, Il, and Bristol, TN: Acura Pharmaceuticals, Inc., and King Pharmaceuticals, Inc., October 13, 2008. Available from: http://www.acurapharm. com/Press%20Releases/pr10132008.htm. [Accessed 27, October 2008]
17. Elite Pharmaceuticals, Inc. reports opioid abuse-resistant products gaining momentum. Elite provides update on company's progress and projected milestones [press release]. Northvale, NJ: Elite Pharmaceuticals, Inc., March 31, 2008. Available from: http://www.elitepharma.com/investor-relations.asp? goto=296. [Accessed 23, October 2008]
18. Webster LR. PTI-821: sustained-release oxycodone using gel-cap technology. Expert Opin Invest Drugs 2007;16(3):359-366 (Pubitemid 46394860)
19. Gilderman L, Butera P, Gilmore D, et al. Remoxy™: a new opioid drug with effective analgesia and abuse-resistance. Program and abstracts of the 25th Annual Scientific Meeting of the American Pain Society, San Antonio, USA (3-6 May 2006):755 (Poster)
20. Friedmann N, Butera P, Klutzaritz D, et al. Abuse-resistant, long-acting oxycodone treats chronic pain in a large Phase III study. International Association for the Study of Pain. 2008. Glascow, Scotland
21. Wallace M, Skowronski R, Khanna S, et al. Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). Curr Med Res Opin 2007;23(5):981-989 (Pubitemid 46799580)
22. Neuromed initiates pivotal Phase 3 clinical trial of NMED-1077 for chronic pain [press release]. Conshohocken, PA and Vancouver, BC: Neuromed Pharmaceuticals, November 1, 2007. Available from: http://www.neuromed.com/news/ pressr. php?nr=4&txt=&pyear=2007. [Accessed 23, October 2008]
23. Sabatowski R, Giesecke T. Pharmacotherapy of chronic, non-tumor related pain. Efficacy, tolerability and patient benefit of an oral osmotic system with hydromorphone. MMW Fortschr Med 2007;149(Suppl 3):119-124
24. Sathyan G, Sivakumar K, Thipphawong J. Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol. Curr Med Res Opin 2008;24(1):297-305 (Pubitemid 351160261)
25. IntelliPharmaCeutics announces successful completion of a pilot clinical trial for its abuse and alcohol resistant sustained release oxycodone [press release]. Toronto: IntelliPharmaCeutics Corp., March 27, 2008. Available from: http://newsblaze. com/story/2008032710330300004.pnw/ topstory.html. [Accessed 23, October 2008]
26. Collegium Pharmaceutical Inc., announces the filing of IND for abuse deterrent sustained release opioid product [press release]. Cumberland, RI: Collegium Pharmaceutical, Inc., June 15, 2007. Available from: http://www.acurapharm.com/Press%20Releases/pr10132008.htm. [Accessed 27, October 2008]
27. TheraQuest receives FDA fast track designation for Tramadol ER in painful HIV-associated neuropathy [press release]. Blue Bell, PA: TheraQuest Biosciences, LLC, April 18, 2006
28. TheraQuest's abuse deterrent tramadol ER IND for neuropathic pain accepted by FDA. Blue Bell, PA: TheraQuest Biosciences, LLC, February 6, 2006. Available from: http://www.pipelinereview.com/content/view/638/105/. [Accessed 27, October 2008]
29. Pedersen AV. Erosion-based drug delivery. Manufacturing Chemist, November 2006. Available from: http://www.egalet.com/press-releases.aspx. [Accessed 19, November 2008]
30. Purdue Pharma L.P. Meeting Background Material. Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM). May 5, 2008. Available from: http://www.fda.gov/OHRMS/DOCKETS/ac/08/briefing/2008-4356b1-02-Purdue.pdf [Last accessed online 8 January 2009].
31. Wright C 4th, Kramer ED, Zalman MA, et al. Risk identification, risk assessment, and risk management of abusable drug formulations. Drug Alcohol Depend 2006;83(Suppl 1):S68-76
32. Comer SD, Sullivan MA, Whittington RA, et al. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology 2008;33(5):1179-1191
33. Friedmann N, de Kater AW, Butera PG, et al. RemoxyTM: a novel drug candidate, deters oxycodone abuse in humans. Presented at 21st annual meeting of the American Academy of Pain Medicine, 2005