title: Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
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.
  
  
  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.
  
  
  METHODS
  Primary efficacy endpoint was the sum of pain-intensity difference scores during the 48 hours (SPID(48)) 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 SPID(48) (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.
authors.affiliation: Premier Research Group, Austin, Texas 78705, USA. Stephen.daniels@premier-research.com
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Daniels
authors.forename: Ron J
authors.initials: RJ
authors.lastname: Spivey
authors.forename: Sonia
authors.initials: S
authors.lastname: Singla
authors.forename: Michael
authors.initials: M
authors.lastname: Golf
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Clark
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006215:Hallux Valgus / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage* / Q000009:adverse effects; D009985:Orthopedics; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D012720:Severity of Illness Index; D013607:Tablets; D016896:Treatment Outcome; D014481:United States; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D010919:Placebos; D013607:Tablets; D014665:Vasodilator Agents; D009525:Niacin; D010098:Oxycodone