ARTICLE | Clinical News

Oxycodone-naltrexone: Phase III data

January 27, 2014 8:00 AM UTC

Top-line data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that ALO-02 met the primary endpoint of improving mean daily average pain NRS scores from baseline to the final 2 weeks of the 12-week treatment period vs. placebo. The most common adverse events were nausea, vomiting and diarrhea. Patients who achieved a stable and effective dose of twice-daily 10-80 mg ALO-02 during a 4-6 week open-label titration period were randomized to either maintain their current dose regimen of ALO-02 or were tapered to placebo in the 12-week, double-blind treatment period. ...