title: Twelve-month, open-label assessment of long-term safety and abuse potential of hydrocodone extended-release formulated with abuse-deterrence technology in patients with chronic pain.
abstract: OBJECTIVE
  To evaluate long-term safety of hydrocodone extended-release (ER) formulated with CIMA(®) Abuse-Deterrence Technology platform.
  
  
  METHODS
  Phase 3, open-label study.
  
  
  METHODS
  Sixty-one US study centers.
  
  
  METHODS
  Patients with chronic pain newly enrolled or rolled over from a 12-week, placebo-controlled hydrocodone ER study; 330 patients enrolled, 329 patients received study drug, and 189 completed the study.
  
  
  METHODS
  After titrating to an analgesic dose (15-90 mg every 12 hours), patients received ≤ 52 weeks of open-label treatment.
  
  
  METHODS
  
  
  
  RESULTS
  adverse events (AEs), vital signs, laboratory values, electrocardiograms, and audiometry. Abuse potential: drug loss and diversion, Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R), Addiction Behaviors Checklist (ABC), Current Opioid Misuse Measure (COMM) questionnaires, and Patient Global Assessment (PGA) of pain control.
  
  
  RESULTS
  Of 329 patients who received ≥ 1 hydrocodone ER dose, 284 (86 percent) reported ≥ 1 AE and 27 (8 percent) experienced ≥ 1 serious AE. Sixty-two (19 percent) patients withdrew because of AEs, and two AEs leading to death were reported. No serious AEs or AEs leading to death were considered treatment related by the investigator. There were no clinically meaningful trends in other safety assessments. SOAPP-R, ABC, and COMM scores demonstrated low risk of aberrant drug-related behavior. Good/excellent PGA responses were reported by 20 percent of patients at baseline and 75 percent at endpoint. The incidence of drug loss (11 percent) and diversion (2 percent) was low.
  
  
  CONCLUSIONS
  Hydrocodone ER demonstrated acceptable safety when administered for ≤ 12 months in patients with chronic pain. Low occurrence of aberrant drugrelated behavior may support the abuse-deterrence properties of hydrocodone ER.
authors.affiliation: Assistant Clinical Professor, Nova Southeastern Medical College, Fort Lauderdale, Florida; Medical Director, Gold Coast Research, LLC, Plantation, Florida.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Hale
authors.affiliation: Medical Monitor, Teva Pharmaceuticals, Frazer, Pennsylvania.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Zimmerman
authors.affiliation: Associate Director, Statistics, Teva Pharmaceuticals, Frazer, Pennsylvania.
authors.forename: Yuju
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Vice President, Global Clinical Development, Pain Therapeutic Area Head, Teva Pharmaceuticals, Frazer, Pennsylvania.
authors.forename: Richard
authors.initials: R
authors.lastname: Malamut
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D010147:Pain Measurement / Q000379:methods; D015813:Substance Abuse Detection / Q000379:methods*; D013997:Time Factors; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D006853:Hydrocodone