title: An Analysis of Rescue Medication Utilization from a 3-Month, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Chronic Low Back Pain Treated with Single-Entity, Twice-Daily, Extended-Release Hydrocodone.
abstract: OBJECTIVE
  To evaluate the durability of pain relief provided by a new formulation of single-entity, hydrocodone extended-release (ER) (Zohydro(®) ER) throughout the 12-hour dosing interval by examining patterns of rescue medication use.
  
  
  METHODS
  Phase 3, enriched enrollment, randomized withdrawal study with an open-label, conversion/titration phase (≤6 weeks) followed by a placebo-controlled, double-blind treatment phase (12 weeks).
  
  
  METHODS
  Fifty-seven study sites in the United States enrolled patients.
  
  
  METHODS
  One hundred and fifty-one opioid-experienced subjects with moderate to severe chronic low back pain who were treated with hydrocodone ER once every 12 hours.
  
  
  METHODS
  Post hoc analysis of rescue medication use by frequency and distribution of use following the morning and evening dose of hydrocodone ER.
  
  
  RESULTS
  No rescue medication was used following the morning or evening dose of hydrocodone ER during 36.0% and 76.7% of the dosing days, respectively. Time distribution of rescue medication use showed that 79.3% of all rescue medication doses were administered following the morning dose, with the highest rate of usage (46.2%) occurring 4-8 hours postdose, followed by 18.7% and 14.4% usage 0-4 and 8-12 hours postdose, respectively. Examination of the three 4-hour intervals following the evening dose of hydrocodone ER revealed similar minimal rescue medication use (5.6-8.2%).
  
  
  CONCLUSIONS
  End-of-dose failure was not observed based on the use of rescue medication after administration of single-entity, twice daily, hydrocodone ER capsules (Zohydro ER).
authors: Clinical Research, International Clinical Research Institute, Overland Park, Kansas.|Department of Rehabilitation Medicine Kansas University Medical Center, Kansas City, Kansas.
authors: Srinivas
authors: S
authors: Nalamachu
authors: Department of Anesthesiology, State University of New York, Buffalo, New York.|Pain Medicine, Roswell Park Cancer Institute, Buffalo, New York.
authors: Oscar A
authors: OA
authors: deLeon-Casasola
authors: Medical and Scientific Affairs, Zogenix, Inc., Emeryville, California, USA.
authors: Cynthia Y
authors: CY
authors: Robinson
authors: Medical and Scientific Affairs, Zogenix, Inc., Emeryville, California, USA.
authors: Bradley S
authors: BS
authors: Galer
authors: Medical and Scientific Affairs, Zogenix, Inc., Emeryville, California, USA.
authors: Errol
authors: E
authors: Gould
authors: Medical and Scientific Affairs, Zogenix, Inc., Emeryville, California, USA.
authors: Arnold
authors: A
authors: Gammaitoni
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage; D059350:Chronic Pain / Q000175:diagnosis* / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage*; D008137:Longitudinal Studies; D017116:Low Back Pain / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects*; D015990:Placebo Effect; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D006853:Hydrocodone
keywords: Breakthrough Pain; Chronic Pain; Durability; End-of-Dose Failure; Hydrocodone Extended-Release; Rescue Medication