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 enrollment in the double-blind crossover portion of this clinical study. Enrollment is continuing in the safety portion of this trial and a second Phase III trial to meet the requirements for additional safety data. The company expects to provide further updates on the status of the Rapinyl clinical development program early in 2008.
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.
David Lee, chief scientific officer of Endo Pharmaceuticals, said: “We remain confident that Rapinyl’s quick dissolution and rapid absorption profile make it a potentially attractive treatment for breakthrough cancer pain.”