Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery

Current Medical Research and Opinion

Volumn 27, Issue 3, 2011, Pages 593-603

  Daniels, Stephen E ^a,b   Spivey, Ron J ^c   Singla, Sonia ^a   Golf, Michael ^a,b   Clark, Francis J ^a,b  

^a Premier Research   (United States)

^b Acura Pharmaceutical Technologies Inc ^*

^c Lotus Clinical Research Inc   (United States)

Author keywords

Abuse deterrent; Bunionectomy; Opioid; Oxycodone; Pain; Tamper resistant

Indexed keywords

KETOROLAC TROMETAMOL; NICOTINIC ACID; OXYCODONE; PLACEBO;

ADULT; AGED; ANALGESIA; ARTICLE; BUNIONECTOMY; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; ERYTHEMA; FEMALE; FLUSHING; HEADACHE; HOT FLUSH; HUMAN; HYPERHIDROSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA AND VOMITING; PAIN ASSESSMENT; PARESTHESIA; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE INFECTION; POSTOPERATIVE PAIN; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; SWELLING; SYNCOPE; TABLET FORMULATION; TREATMENT RESPONSE; URTICARIA; WOUND INFECTION; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; ALGORITHMS; ANALGESICS, OPIOID; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HALLUX VALGUS; HUMANS; MALE; MIDDLE AGED; NIACIN; ORTHOPEDICS; OXYCODONE; PAIN, POSTOPERATIVE; PLACEBOS; SEVERITY OF ILLNESS INDEX; TABLETS; TREATMENT OUTCOME; UNITED STATES; VASODILATOR AGENTS; YOUNG ADULT;

EID: 79951595218     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2010.548291     Document Type: Article

References (26)

1. Institute for Clinical Systems Improvement. Health Care Guideline: Assessment and Management of Acute Pain. 6th edn. Bloomington, MN: Institute for Clinical Systems Improvement, 2008. Available at: http://www.icsi.org/pain- acute/ pain-acute-assessment-and-management-of-3.html [Last accessed 19 May 2009]
2. Chou R, Fanciullo GJ, Fine PG, et al. American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy. J Pain 2009;10:113-30
3. Rosenquist RW, Rosenberg J. Postoperative pain guidelines. Reg Anesth Pain Med 2003;28:279-88 (Pubitemid 36936251)
4. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force. Arch Intern Med 2005; 165:1574-80 (Pubitemid 41124150)
5. Casey CY, Greenberg MA, Nicassio PM, et al. Transition from acute to chronic pain and disability: a model including cognitive, affective, and trauma factors. Pain 2008;134:69-79 (Pubitemid 350258593)
6. Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet 2006;367:1618-25 (Pubitemid 43674227)
7. Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother 2009;9:723-44
8. Bhamb B, Brown D, Hariharan J, et al. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin 2006;22:1859-65 (Pubitemid 44449242)
9. Substance Abuse and Mental Health Services Administration. Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings (Office of Applied Studies, NSDUH Series H-38A, HHS Publication No. SMA10-4586 Findings). Rockville, MD, 2010. Available at: http://oas.samhsa. gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf [Last accessed 23 December 2010]
10. Institute of Medicine. Niacin. In: Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy of Sciences/The National Academies Press, 1998:123-49
11. Niacor [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc., 2007
12. Freeland DV, Spivey R. Phase II multiple-dose study of the safety and toler-ability of niacin 30 mg and 60 mg combined with oxycodone HCl 5 mg versus oxycodone HCl 5 mg alone in healthy adult volunteers. Poster presented at: 71st Annual Meeting of the College on Problems of Drug Dependence, 20-25 June 2009, Reno/Sparks, NV, USA
13. Wood R, Spivey R. Phase II study to evaluate the dose response for flushing, safety, and tolerability of escalating doses of niacin in fasted and fed healthy adult volunteers. Poster presented at: 71st Annual Meeting of the College on Problems of Drug Dependence, 20-25 June 2009, Reno/Sparks, NV, USA
14. Jasinski DR. A phase II, single-center, randomized, double-blind assessment of the subjective effects of Acurox® (oxycodone HCl/niacin) tablets in volunteers with a history of opioid abuse. Poster presented at: 40th Annual Medical-Scientific Conference of the American Society of Addiction, 30 April - 3 May, 2009, New Orleans, LA, USA. Poster 34
15. Daniels SE, Upmalis D, Okamoto A, et al. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin 2009; 25:765-76
16. Ford LB. Soft-tissue bunionectomy in podiatric surgery. Clin Podiatr Med Surg 1991;8:63-70
17. Desjardins PJ, Traylor L, Hubbard RC. Analgesic efficacy of preoperative parecoxib sodium in an orthopedic pain model. J Am Podiatr Med Assoc 2004;94:305-14 (Pubitemid 38721468)
18. Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manag 2003; 25:406-11 (Pubitemid 36506668)
19. Daniels S, Casson E, Stegmann JU, et al. A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin 2009; 25:1551-61
20. Desjardins PJ, Black PM, Daniels S, et al. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin 2004;20:1523-37 (Pubitemid 39457541)
21. Niaspan [package insert]. North Chicago IL: Abbott Laboratories, 2010
22. Oxycodone hydrochloride tablets [package insert]. St. Louis, MO: Mallinckrodt, 2007.
23. Stegmann J-U, Weber H, Steup A, et al. The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery. Curr Med Res Opin 2008;24: 3185-96
24. Food and Drug Administration Medication Guide for Nonsteroidal Anti-inflammatory Drugs. Available at http://www.fda.gov/Drugs/DrugSafety/ UCM085729 [Last accessed 7 July 2010]
25. Mendoza TR, Chen C, Brugger A, et al. Lessons learned from a multiple-dose post-operative analgesic trial. Pain 2004;109:103-9 (Pubitemid 38479775)
26. Acurox (oxycodone HCl, USP and niacin, USP) Tablets: NDA 22-451. Briefing information for a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Palatine, IL: Acura Pharmaceuticals, Inc., April 22, 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/ Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/ UCM209143.pdf [Last accessed 4 Nov 2010]