Endo's Oxymorphone Extended-Release Will Need New Trial

The additional clinical trial will address potential bias in the statistical analysis of the two fixed-dose Phase III efficacy trials. Endo expects to submit a revised NDA in 2005 following "approvable" letter.

Endo expects to submit a revised NDA for its oxymorphone extended-release tablets to FDA in 2005.

The timetable depends in part on the design of the additional trial that Endo will need to conduct for the opioid analgesic product.

"No determination has yet been made about the duration of the trial or the number of patients that will need to be enrolled," Endo said, but "once the trial protocol has been approved by the FDA, the company will be in a better position to offer guidance on timing."

The decision to conduct a new trial follows a meeting with FDA regarding the approvable letter, which was issued in October.

"The FDA has indicated that it is concerned that the statistical analysis of the two fixed-dose Phase III efficacy trials may have been favorably biased by the inclusion of data from patients who did not complete the trials. The design of this additional clinical trial is intended to address this issue."

"This study will complement the successful Phase III trial that the company believes the FDA has accepted as demonstrating efficacy in the intended patient population," Endo said.

The NDA was submitted in December 2002 for treatment of moderate-to-severe pain in patients requiring continuous opioid therapy for an extended period of time. The Phase III program included patients with osteoarthritis pain, chronic low back pain, and cancer pain.

In March, Endo said it would conduct an additional short-term repeat-dose study for its oxymorphone immediate-release tablets, which also received an approvable letter in October (¹ (Also see "Endo Plans Additional Oxymorphone IR Study" - Pink Sheet, 1 Apr, 2004.)).The extended-release product uses Penwest delivery technology.

- M. Nielsen Hobbs