title: Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain.
abstract: OBJECTIVE
  To evaluate long-term use of Hysingla(®) ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain.
  
  
  METHODS
  This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20-120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in "average pain over the last 24 h" (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use.
  
  
  RESULTS
  Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks.
  
  
  CONCLUSIONS
  HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of treatment.
authors.affiliation: a Arizona Research Center , Phoenix , AZ , USA.
authors.forename: Louise
authors.initials: L
authors.lastname: Taber
authors.affiliation: b Clinical Research and Development, Purdue Pharma L.P ., Stamford , CT , USA.
authors.forename: Shau Yu
authors.initials: SY
authors.lastname: Lynch
authors.affiliation: b Clinical Research and Development, Purdue Pharma L.P ., Stamford , CT , USA.
authors.forename: Ellie
authors.initials: E
authors.lastname: He
authors.affiliation: b Clinical Research and Development, Purdue Pharma L.P ., Stamford , CT , USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Ripa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000627:therapeutic use; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D006853:Hydrocodone
keywords: Abuse-deterrent properties; Chronic pain; Hydrocodone bitartrate; Long-term opioid therapy; Long-term safety; Once-daily; Opioid