title: Long-term safety of Remoxy® (extended-release oxycodone) in patients with moderate to severe chronic osteoarthritis or low back pain.
abstract: OBJECTIVE
  Evaluate the long-term safety, tolerability, and efficacy of Remoxy® (extended-release oxycodone) in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.
  
  
  METHODS
  Open-label, 12-month, phase 3 trial.
  
  
  METHODS
  Fifty-nine US sites.
  
  
  METHODS
  Men and women with moderate to severe hip and/or knee pain caused by osteoarthritis or persistent moderate to severe low back pain.
  
  
  METHODS
  Remoxy 5 mg twice daily, which could be increased in fixed increments up to 80 mg twice daily.
  
  
  METHODS
  Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, and electrocardiograms. Efficacy was assessed through ratings of pain intensity, quality of analgesia, and global assessment of study drug.
  
  
  RESULTS
  Of the 828 patients enrolled, 823 received ≥1 dose of Remoxy, with 469 exposed for ≥180 days and 381 for ≥358 days. At least one AE was experienced by 678 patients (82%), the most common of which were opioid related, including constipation, nausea, and somnolence; 173 patients (21%) discontinued treatment because of AEs. No clinically relevant changes were seen in other safety assessments. Mean pain intensity scores decreased significantly from baseline at all time points (P < 0.001). At month 12, quality of analgesia and global assessment of study drug were rated positively (good, very good, or excellent) by 64% and 61% of patients (last observation carried forward), respectively.
  
  
  CONCLUSIONS
  Long-term treatment with Remoxy was safe, well tolerated, and efficacious in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.
authors.affiliation: Pain Therapeutics, Inc., San Mateo, California 94404, USA. nfriedmann@paintrials.com
authors.forename: Nadav
authors.initials: N
authors.lastname: Friedmann
authors.forename: Vicki
authors.initials: V
authors.lastname: Klutzaritz
authors.forename: Lynn
authors.initials: L
authors.lastname: Webster
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018771:Arthralgia / Q000188:drug therapy; D002908:Chronic Disease; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone