Endo Pharmaceuticals Inc, a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc, announced results from the third Phase III clinical trial for its development product MorphiDex.
The primary endpoint of the study was to demonstrate that MorphiDex could reduce the daily morphine requirement and maintain the same degree of pain control over three months in patients with moderate-to-severe pain from osteoarthritis. No statistically significant difference in the primary outcome variable was observed in the MorphiDex group compared to the morphine sulfate alone group. The study also did not meet its secondary endpoint, a reduction in analgesic tolerance for patients administered MorphiDex.
These results confirm the company's belief, as previously announced on October 28, 2002, that the third study, regardless of outcome, would not provide sufficient data to support the filing of an amendment to the MorphiDex New Drug Application (NDA). Also as previously reported, because MorphiDex will not be approved prior to March 31, 2003, the Class A Transferable Warrants and Class B Non-Transferable Warrants will expire on such date and have no economic value.