Endo oxymorphone ER data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Endo's extended-release oxymorphone product shows statistically significant results in a Phase III study of patients with moderate to severe low back pain, the firm reports Oct. 3. In the 12-week, 142-patient study of opioid-experienced patients, oxymorphone ER showed a significant change in average pain intensity compared to placebo (p<0.0001). The results are similar to those from an initial Phase III trial in opioid-naïve patients; Endo announced the results of that initial pivotal trial, conducted under a special protocol assessment, in August. Endo continues to project a complete response to dual "approvable" letters for its ER and immediate-release oxymorphone formulations in 2006...