Dose Conversion and Titration with a Novel, Once-Daily, OROS^® Osmotic Technology, Extended-Release Hydromorphone Formulation in the Treatment of Chronic Malignant or Nonmalignant Pain

The OROS^® osmotic technology, extended-release hydromorphone formulation tablet. This formulation consists of a drug layer and a push layer enclosed in a semipermeable tablet shell membrane that is pervious to water but not the drug. As water is absorbed from the gastrointestinal tract, the push layer expands and presses on the drug layer, slowly releasing hydrated hydromorphone through a laser-drilled orifice in the tablet shell.

Patient disposition.

Percent of patients by the number of titration steps required in reaching a stable dose of ER hydromorphone. Dose stabilization was attained by 73.8% of patients (298/404). Among these, 70.1% (209/298) were stabilized with ≤2 titration steps.

Comparisons of mean ± standard deviation (SD) pain intensity ratings from the Brief Pain Inventory between pretreatment (Visit 2 at the end of the prior opioid stabilization phase) and endpoint (Visit 5 or the last observation carried forward during treatment, whether at Visits 3 or 4) in the intent-to-treat analysis. Pain at its worst, at its least, and on average in the last 24 hours and pain right now were rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). *P < 0.001 when comparing pretreatment to endpoint (Wilcoxon signed rank test). ^†P < 0.01 when comparing pretreatment to endpoint (Wilcoxon signed rank test).

Comparisons of mean ± standard deviation (SD) pain interference ratings from the Brief Pain Inventory between pretreatment (Visit 2 at the end of the prior opioid stabilization phase) and endpoint (Visit 5 or the last observation carried forward during treatment, whether at Visits 3 or 4) in the intent-to-treat analysis. Pain interference of function (general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life) was rated on a scale from 0 (no interference) to 10 (complete interference). *P < 0.0001 when comparing pretreatment to endpoint (Wilcoxon signed rank test).