title: A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
abstract: OBJECTIVE
  To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months.
  
  
  METHODS
  Open-label, single-arm safety study.
  
  
  METHODS
  Thirty-two US research centers (ClinicalTrials.gov identifier NCT01428583).
  
  
  METHODS
  Three hundred ninety-five adults (opioid experienced and opioid naïve) with moderate-to-severe chronic noncancer pain (CNCP).
  
  
  METHODS
  Open-label, oral ALO-02 capsules, daily dose ranging from 20 to 160 mg oxycodone for up to 12 months.
  
  
  METHODS
  Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure).
  
  
  RESULTS
  A total of 193 (48.9 percent) patients received ALO-02 for ≥181 days and 105 (26.6 percent) patients for ≥361 days. The most common treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), vomiting (13.9 percent), and headache (11.6 percent). The most common drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS total score below the level for mild withdrawal symptoms at every visit throughout the study. Pain severity scores as measured by the short Form of the Brief Pain Inventory (BPI-SF) decreased over time.
  
  
  CONCLUSIONS
  Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients. ALO-02 demonstrated a safety profile consistent with extended-release opioids and the expected analgesic efficacy. The addition of sequestered naltrexone had no significant clinical effect on patients when taken as directed.
authors.affiliation: Columbus Clinical Research, Columbus, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Arora
authors.affiliation: Pfizer Inc., Durham, North Carolina.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.affiliation: Allegheny Pain Management, Altoona, Pennsylvania.
authors.forename: Drass
authors.initials: D
authors.lastname: Michael
authors.affiliation: Future Search Trials of Neurology, Austin, Texas.
authors.forename: John D
authors.initials: JD
authors.lastname: Hudson
authors.affiliation: Pfizer Inc., Groton, Connecticut.
authors.forename: Ray
authors.initials: R
authors.lastname: Clemmer
authors.affiliation: Pfizer Inc., Durham, North Carolina.
authors.forename: Paul
authors.initials: P
authors.lastname: Meisner
authors.affiliation: Pfizer Inc., Durham, North Carolina.
authors.forename: Glenn C
authors.initials: GC
authors.lastname: Pixton
authors.affiliation: Pfizer Inc., Durham, North Carolina; Duke University Medical Center, Durham, North Carolina.
authors.forename: Veeraindar
authors.initials: V
authors.lastname: Goli
authors.affiliation: Pfizer Inc., Durham, North Carolina; Duke University Medical Center, Durham, North Carolina.
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Sommerville
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004338:Drug Combinations; D054796:Drug Dosage Calculations; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D010147:Pain Measurement; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009292:Narcotic Antagonists; C557247:oxycodone naloxone combination; D009270:Naloxone; D010098:Oxycodone