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Phase 3 Open-Label Study Comparing Tapentadol Extended Release Tablets to Oxycodone Controlled Release Tablets Published by Pain Practice
Date:7/19/2010

creased to 4.4 and 4.5.

"We are encouraged by these study results as they illustrate the tolerability of tapentadol ER compared with oxycodone CR, a standard chronic pain treatment," said Dr. Bruce Moskovitz, Therapeutic Area Leader for Pain, Ortho-McNeil Janssen Scientific Affairs, LLC. "We are pleased about the possibility of bringing this important investigational compound forward to patients in the future."

This study of tapentadol ER examined its long-term safety and tolerability compared to oxycodone CR and the primary objective of this study was to evaluate the safety of twice-daily doses of tapentadol ER (100 to 250 mg) over one year. Patients were randomized in a 4:1 ratio to receive controlled, adjustable, oral, twice-daily doses of tapentadol ER (100-250 mg) or oxycodone HCl CR (20-50 mg) in open-label treatment for up to one year. There were 1,117 patients in the study that received at least one dose of study medication (tapentadol ER, n=894; oxycodone CR, n=223). Demographic and baseline characteristics were similar in the two treatment groups.

The overall incidence of patients experiencing at least one TEAE in the study was 85.7 percent in the tapentadol ER group and 90.6 percent in the oxycodone CR group. The most common TEAEs (reported in the study by greater than 10 percent in either treatment group) included constipation, nausea, dizziness, somnolence, vomiting, headache, fatigue and pruritus. In addition to the gastrointestinal TEAEs reported above, tapentadol ER was associated with lower incidences of dizziness (tapentadol ER, 14.8 percent; oxycodone CR, 19.3 percent), fatigue (tapentadol ER, 9.7 percent; oxycodone CR, 10.3 percent), and pruritus (tapentadol ER, 5.4 percent; oxycodone CR, 10.3 percent). Oxycodone CR was associated with lower incidences of somnolence (tapentadol ER, 14.9 percent; oxycodone CR, 11.2 percent
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