High-Dose Controlled-Release Oral Oxycodone Safety Reported

VIENNA, Austria—Daily doses of controlled-release oral oxycodone (OxyContin, Oxygesic) exceeding 80 mg are as safe as lower doses when therapy is individualized, researchers from Purdue Pharma L.P. reported at the 9th World Congress on Pain.

Drs. Robert F. Reder and Minggao Shi based this conclusion on a retrospective review of data from eight clinical trials of OxyContin. The trials included 639 patients with chronic pain syndromes who were receiving OxyContin.

Controlled-release oxycodone is an oral opioid analgesic taken every 12 hours. Dosages were individualized and titrated to efficacy.

“Of these 639 patients, 343 (54%) took 80 mg or more of controlled-release oxycodone per day for at least 1 day during their therapy,” Dr. Reder reported. During those high-dose days, the median total daily dose was 120 mg (range, 80 mg to 1,360 mg).

The incidence of adverse events commonly associated with opioid therapy was not significantly higher in this high-dose group of patients. For example, constipation occurred in 10.2% of the high-dose patients, compared with 8.3% of all patients.

“This data review indicates that high-dose, controlled-release oral oxycodone therapy is associated with similar efficacy and safety as the overall treatment group involving all dose levels, when therapy is individualized and titrated to effect,” Dr. Reder concluded.