Endo Pharmaceuticals Inc., said an interim analysis of its late stage clinical trial data showed that its cancer pain treatment candidate Rapinyl is effective, and met all primary and secondary trial goals.
The data from the analysis of 61 patients demonstrated that Rapinyl met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). In addition, all the secondary endpoints were met. Statistically significant separation from placebo on mean pain intensity difference was seen as early as 10 minutes.
On the basis of these results and in accordance with the predetermined criteria of the interim analysis, Endo is terminating enrolment in the double-blind crossover portion of this clinical study. Enrolment is continuing in the safety portion of this trial and a second phase III trial to meet the requirements for additional safety data. Rapinyl is an oral, fast-dissolving tablet of fentanyl intended for the treatment of breakthrough cancer pain. Endo licensed the exclusive rights to develop and market Rapinyl in North America from Orexo AB.
"We are extremely pleased by the outcome of this analysis, which we believe demonstrates that Rapinyl can be an effective treatment for breakthrough pain in cancer patients," said David A. Lee, M.D., Ph.D., Chief Scientific Officer. "We remain confident that Rapinyl's quick dissolution and rapid absorption profile make it a potentially attractive treatment for breakthrough cancer pain."
Endo will conduct a thorough analysis of the data to determine the next course of action, including the possibility of filing a New Drug Application (NDA) based on these results. It expects to provide further updates on the status of the Rapinyl clinical development programme early in 2008.
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike.