Hydrocodone Bitartrate ER Shown to be Effective for Chronic Pain

LAS VEGAS, NV—Hydrocodone Bitartrate Extended-Release (ER), the first single-entity hydrocodone formulation, may provide a new opioid option for subjects with chronic pain that is not alleviated by their current treatment, according to a study presented at PAINWeek 2012.

Currently, hydrocodone is only available in combination with nonopioid analgesics such as acetaminophen, which may prevent titration of hydrocodone to therapeutic levels. Richard Rauck, MD, from Carolinas Pain Institute, Center for Clinical Research, and Wake Forest University School of Medicine, Winston-Salem, NC, and colleagues conducted a multicenter, open-label study to evaluate long-term safety and efficacy of hydrocodone bitartrate ER in subjects with moderate-to-severe chronic pain requiring around-the-clock opioid therapy for an extended period of time. The study was comprised of a conversion/titration (C/T) phase (1–6 weeks) followed by a treatment phase (<48 weeks) in opioid-experienced subjects with chronic pain.

During C/T, a total of 638 patients were converted to hydrocodone bitartrate ER using initial doses that were 20–30% less than the equivalent dose calculated by the Opioid Conversion Table. During the treatment phase, 424 patients received their individualized dose and were allowed up to 2 tablets of hydrocodone bitartrate 5mg/acetaminophen 500mg daily for breakthrough pain. Safety endpoints included adverse events and laboratory parameters. In addition, efficacy endpoints included change in pain intensity (PI) score (0–10 numerical rating scale) and selected Brief Pain Inventory (BPI) questions about pain severity, relief with medication, and interference with activities.

Daily pain intensity scores improved from screening to end of treatment (mean±SD change, -2.3±2.5). Changes in BPI scores from screening to end of treatment showed improvement in pain severity, relief achieved with medication, and interference with activities. The most common adverse events were constipation (11% in C/T and 13% in treatment phase), nausea (11% in C/T phase) and back pain (11% in treatment phase). No statistical testing was performed.

Based on study results, Dr. Rauck concluded that hydrocodone bitartrate ER exhibited, “a safety profile consistent with that of other opioids” and appeared effective for managing chronic pain. This agent will provide another option for treatment of moderate-to-severe chronic pain without the dose limiting effect of acetaminophen.