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. Issue 12 (24th August 2015)

• Record Type: Journal Article
• Authors: Nalamachu, Srinivas; deLeon‐Casasola, Oscar A.; Robinson, Cynthia Y.; Galer, Bradley S.; Gould, Errol; Gammaitoni, Arnold
• Is Part Of: Pain medicine. Volume 16:Issue 12(2015)
• Page Start: 2338
• Page End: 2343
• Publication Date: 2015-08-24
• Subjects: Hydrocodone Extended‐Release -- End‐of‐Dose Failure -- Rescue Medication -- Durability -- Breakthrough Pain -- Chronic Pain; Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesics -- Periodicals; Pain -- Periodicals; Pain Management -- Periodicals; Douleur -- Périodiques; Douleur -- Traitement -- Périodiques; Analgésiques -- Périodiques; Analgésique; Soulagement de la douleur; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.047205
• DOI: 10.1111/pme.12831
• Languages: English
• ISSNs: 1526-2375

Abstract

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. 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).