Oxycodone-naltrexone: Additional Phase III data

Additional data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that a greater proportion of patients receiving ALO-02 achieved a >=30% reduction (57.5% vs. 44%, p=0.0248) and a >=50% reduction (39.7% vs. 29.9%, p=0.0874) from baseline in mean daily average pain NRS scores from baseline during the final 2 weeks of the 12-week treatment period vs. placebo. 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. Data were presented at the American Pain Society meeting in Tampa. ...