ENDO ANNOUNCES RESULTS OF OXYMORPHONE STUDY

Endo Pharmaceuticals has reported the results from the Phase III clinical trial of its investigational drug oxymorphone extended-release tablets (oxymorphone ER) that was conducted under the FDA's special protocol assessment process. In this multicenter, randomized, double-blind, parallel group trial, the safety and efficacy of oxymorphone ER were compared with placebo in 205 opioid-naive patients with moderate-to-severe chronic low back pain.

Results of the study, conducted in response to the FDA's request for additional clinical data to support Endo's new drug application for this developmental product, demonstrated statistically significant difference in pain scores between oxymorphone ER and placebo during a 12-week treatment period, during which the drug was administered twice daily. The primary endpoint was change in average pain intensity.

Oxymorphone ER was generally well-tolerated. As expected, the incidence of opioid-related adverse events in the oxymorphone ER group was higher compared to the placebo treatment group.