title: Pharmacokinetic and pharmacodynamic evaluation of oxycodone and naltrexone for the treatment of chronic lower back pain.
abstract: BACKGROUND
  Chronic low back pain (CLBP) is a common and difficult illness to manage. Some individuals with CLBP have pain processing disorders and are also at risk for opioid abuse, misuse; addiction and diversion. Guidelines have been published to guide management; neuromodulation, exercise, mindfulness-based stress reduction and cognitive behavior therapies among other non-pharmacological reduce the pain of CLBP with minimal toxicity. Pharmacological management includes acetaminophen, NSAIDs and antidepressants, mainly duloxetine. Abuse-deterrent opioids have been developed which have been shown to reduce pain and opioid abuse risk. ALO-02 is a tamper-resistant sustained release opioid consisting of extended release oxycodone and sequestered naltrexone. Pivotal studies of ALO-02 have centered on patients with CLBP.
  
  
  METHODS
  This manuscript will review CLBP, the pivotal analgesic and clinical abuse potential studies of ALO-02. The opinion will cover whether opioids should be used for CLBP, when they should be used and opioid choices.
  
  
  CONCLUSIONS
  ALO-02 is one of several opioids which can be considered in the management of CLBP. The outcome to a trial of opioids should be function rather than analgesia. Most analgesic trials for CLBP have had analgesia as the primary outcome and function has not been vigorously studied as an outcome. Opioids should be considered as a trial only when other non-opioid analgesics have failed to improve analgesia and function. Universal precautions should be routinely part of phase III analgesic trial particularly for chronic non-malignant pain.
authors.affiliation: a Cleveland Clinic Lerner School of Medicine , Case Western Reserve University , Cleveland , OH , USA.|b Clinical Fellowship Program, Palliative Medicine and Supportive Oncology Services, Division of Solid Tumor , Taussig Cancer Institute, The Cleveland Clinic , Cleveland , OH , USA.
authors.forename: Mellar P
authors.initials: MP
authors.lastname: Davis
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000818:Animals; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D009271:Naltrexone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D009293:Opioid-Related Disorders / Q000517:prevention & control; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D017410:Practice Guidelines as Topic
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C000608978:oxycodone naltrexone combination; D009271:Naltrexone; D010098:Oxycodone
keywords: Pain; abuse-deterrent; analgesia; back; oxycodone