![Sample our Bioscience journals, sign in here to start your access, Latest two full volumes FREE to you for 14 days]({"type":"image" , "src" : "/sda/5925/TOC-Subject-Sample-2021-Bioscience.jpg"})
Abstract
Objective:
To evaluate the efficacy and safety of two dose strengths of oxycodone hydrochloride (HCl)/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
Research design and methods:
Randomized, double-blind, placebo-controlled, US multicenter, repeat-dose study (Clinicaltrials.gov: NCT00654069). A total of 606 patients aged ≥18 years with moderate-to-severe pain post-bunionectomy were screened, and 405 patients were randomized to receive placebo, 2 × 5/30 mg oxycodone HCl/niacin tablets, or 2 × 7.5/30 mg oxycodone HCl/niacin tablets administered every 6 hours for 48 hours. Ketorolac tromethamine was available as rescue medication.
Main outcome measures:
Primary efficacy endpoint was the sum of pain-intensity difference scores during the 48 hours (SPID48) following the initial dose of study drug. Secondary efficacy endpoints included a responder analysis and use of rescue medication. Safety evaluations included adverse events (AEs), vital signs, and clinical laboratory assessments.
Results:
Both doses of oxycodone HCl/niacin tablets demonstrated superior reductions in pain intensity compared with placebo as evidenced by the SPID48 (p < 0.0001 for both oxycodone HCl/niacin 2 × 5/30 mg and 2 × 7.5/30 mg). AEs were consistent with the known effects of oxycodone HCl and niacin. Most AEs were mild or moderate in intensity, and no serious AEs occurred. There were no discontinuations due to AEs in the placebo group; 2/135 (1.5%) discontinued due to AEs in the 2 × 5/30 mg group and 4/134 (3.0%) in the 2 × 7.5/30 mg group. A limitation of this study was that there was no active comparator arm.
Conclusions:
Oxycodone HCl/niacin tablets (5/30 mg and 7.5/30 mg) provide effective analgesia and are generally well tolerated in patients with moderate-to-severe pain following bunionectomy surgery.
Transparency
Declaration of funding
This study was supported by Acura Pharmaceutical Technologies, Inc., and King Pharmaceuticals®, Inc. Authors of this manuscript served as investigators or consultants for the research or are employed by the sponsor. The authors did not receive compensation for the preparation of this manuscript. They accept sole responsibility for the accuracy of the manuscript, and also had final responsibility for the decision to submit for publication.
Declaration of financial/other relationships
S.E.D., M.G. and F.J.C. have disclosed that they are employees of Premier Research Group Limited, a company sponsored by Acura Pharmaceuticals to conduct this study. R.J.S. has disclosed that he is an employee and stock shareholder of Acura Pharmaceuticals. S.S. has disclosed that she is an employee of Lotus Clinical Research, Inc. and was a paid Clinical Trial Investigator, sponsored by Acura Pharmaceuticals.
The CMRO peer reviewers have disclosed that they have no relevant financial relationships to disclose.
Acknowledgements
Writing and editorial support for this manuscript was provided by Noveida Health, LLC, and Quintiles Medical Communications. Funding for writing and editorial assistance was provided by King Pharmaceuticals®, Inc. The authors acknowledge the contributions of Daniel Solorio and the staff of Premier Research Group. The authors would also like to acknowledge the statistical services of Glenn Pixton, King Pharmaceuticals®, Inc., in the preparation of this manuscript.
Data from this study have been presented at the American Pain Society Annual Meeting held May 7–9, 2009, in San Diego, California; The College on Problems of Drug Dependence Annual Meeting held June 20–25, 2009, in Reno, Nevada; and The American Academy of Pain Management Annual Meeting held October 8–11, 2009, in Phoenix, Arizona.
Notes
*Acurox® with Niacin Tablets. King Pharmaceuticals®, Inc., Bristol, TN, USA.
*Acurox® with Niacin Tablets. King Pharmaceuticals®, Inc., Bristol, TN, USA.