EpiCept says phase 3 trial of LidoPain fails to meet goal

New York, Sept. 5 - EpiCept Corp. said LidoPain SP did not meet its co-primary endpoints in a phase 3 clinical trial in Europe.

In the study of 440 patients who underwent hernia repair surgery, the sterile prescription analgesic patch did not achieve a statistically significant effect relative to a placebo using the primary endpoint of self-assessed pain intensity between four and 24 hours.

LidoPain also failed to achieve the co-primary endpoint of patient use of "rescue" medications, i.e. systemically-delivered analgesics used to alleviate pain.

"We are obviously disappointed that LidoPain SP did not meet its co-primary endpoints, particularly in light of the positive results achieved by the product candidate in its phase 2 trial," said Jack Talley, president and chief executive officer of the Englewood Cliffs, N.J.-based specialty pharmaceutical company. "We will in particular be looking at changes which occurred in going from phase 2 to phase 3."

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