Clinical Trial Results with OROS® Hydromorphone

OROS® hydromorphone is a unique drug delivery system being evaluated for the once-daily oral treatment of moderate to severe chronic pain. Results of dose conversion studies indicate that most patients can be successfully titrated from prior opioid therapy to OROS® hydromorphone using a 5:1 ratio to convert oral morphine equivalents to OROS® hydromorphone in up to two dose titration steps. OROS® hydromorphone is effective in both chronic cancer pain and chronic noncancer pain of moderate to severe intensity. It is at least as effective at controlling chronic pain, reducing the impact of pain on functionality, and improving quality of life as controlled-release morphine (cancer pain) and extended-release oxycodone (osteoarthritis pain). In all studies, OROS® hydromorphone was generally well tolerated, with an adverse event profile similar to that of other long-acting opioid analgesics.