This randomized, double-blinded, placebo-controlled study enrolled patients in the US with moderate-to-severe osteoarthritic pain. Following a titration period, patients were randomized to either twice-daily Remoxy (10-80 mg daily) or placebo for 12 weeks.
The primary endpoint is change in pain scores during the treatment period. Top line results of this study are expected in the fourth quarter of 2007, after the last patient completes the three-month treatment period.
Remoxy is based on Durect’s patented Oradur technology incorporating the opioid oxycodone.