title: 12-Month safety and effectiveness of once-daily hydrocodone tablets formulated with abuse-deterrent properties in patients with moderate to severe chronic pain.
abstract: OBJECTIVE
  To characterize the long-term safety and effectiveness of Hysingla™ ER, single-entity, once-daily, extended-release hydrocodone bitartrate tablets formulated with abuse-deterrent properties (HYD), offering a new treatment option for appropriate patients with chronic pain.
  
  
  METHODS
  An open-label study with a dose-titration period (up to 45 days) and a maintenance period (12 months).
  
  
  METHODS
  A total of 922 patients with chronic nonmalignant and non-neuropathic moderate to severe pain received open-label HYD tablets 20-120 mg; 728 of these achieved a stabilized dose of HYD at the end of dose-titration and entered the maintenance period.
  
  
  RESULTS
  The safety profile was similar to that of other oral opioid analgesics, without new or unexpected safety concerns. The most frequent treatment-emergent adverse events (AEs; ≥ 5 percent) were those commonly associated with the use of systemic µ-opioid analgesics, including nausea, constipation, vomiting, fatigue, dizziness, somnolence, and headache. There were 77 (8 percent) patients with a total of 109 nonfatal treatment-emergent serious AEs. Few patients discontinued due to lack of therapeutic effect overall (6 percent), especially during the 12-month maintenance period (4 percent). Pain relief, sleep, functional health, and activities of daily living all improved at the end of the dose-titration period with HYD. These improvements were maintained through the 12-month maintenance period with stable HYD doses and without increase in concomitant supplemental analgesic medications.
  
  
  CONCLUSIONS
  This long-term study demonstrated the safety and long-term maintenance of analgesic effect of HYD without continued need for dose increase.
authors: Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.
authors: Warren
authors: W
authors: Wen
authors: Medical Director, Arizona Research Center, Phoenix, Arizona.
authors: Louise
authors: L
authors: Taber
authors: Associate Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.
authors: Shau Yu
authors: SY
authors: Lynch
authors: Associate Director, Biostatistics, Purdue Pharma L.P., Stamford, Connecticut.
authors: Ellie
authors: E
authors: He
authors: Executive Medical Director, Clinical Research, Purdue Pharma L.P., Stamford, Connecticut.
authors: Steven
authors: S
authors: Ripa
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000209:etiology / Q000517:prevention & control*; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D006853:Hydrocodone