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.
Design: 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).
Setting: Fifty-seven study sites in the United States enrolled patients.
Subjects: 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).
Keywords: Breakthrough Pain; Chronic Pain; Durability; End-of-Dose Failure; Hydrocodone Extended-Release; Rescue Medication.
Wiley Periodicals, Inc.