Endo Announces Positive Results From Interim Analysis of RAPINYL Phase III Clinical Trial
Endo Pharmaceuticals Inc., a market leader in pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), today reported positive results from the previously announced, planned interim statistical analysis of a Phase III, placebo-controlled, double-blind trial of its development product, RAPINYL(TM). 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. 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." He added that 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 program early in 2008.
The company noted that although this planned interim analysis was only intended to determine efficacy and not tolerability, those adverse events that were reported were consistent with what is usually observed with other opioids.
About Endo
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. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at www.endo.com.
Forward-Looking Statements
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