A Multicenter, Open-label Study of Tapentadol Extended-release Tablets in Opioid-naïve and Opioid-switching Subjects with Moderate to Severe Cancer Pain

ABSTRACT

The present multicenter, open-label study evaluated the efficacy and safety of tapentadol ER administered at 50 mg/day to 500 mg/day in opioid-naive and opioid-switching subjects with moderate to severe cancer pain. For opioid-naive subjects, the initial dose was tapentadol ER 50 mg/day. For opioid-switching subjects, the initial dose was determined depending on previously used opioid and was dose-adjusted for each subject. The study design consists of two parts of titration period and maintenance period to which a patient who achieves dose adjustment can proceed. The percentage of subjects achieving dose adjustment in the titration period was 93.3% for opioid-naive subjects and 80.6% for opioid-switching subjects. The percentage of subjects who maintained adequate analgesia throughout the maintenance period (primary endpoint) was 89.7% for opioid-naive subjects and 92.9% for opioid-switching subjects. The most frequent adverse events were were nausea, vomiting, somnolence, and constipation, all of which were commonly reported with the use of opioids. These findings showed that tapentadol ER was well tolerated in the dose range of 50 mg/day to 500 mg/day.