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Endo halts Rapinyl trial early, plans submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Endo may file an NDA for its cancer pain management drug Rapinyl based on highly significant Phase III interim results, firm says Dec. 17. The 61 patients given the oral, fast-dissolving fentanyl tablet, licensed from Orexo AB in 2004, showed a statistically significant difference in the primary endpoint, Sum of Pain Intensity Difference from baseline to 30 minutes, and secondary endpoints. Results were seen as early as 10 minutes. Endo is terminating enrollment in the double-blind crossover portion of the trial based on the interim efficacy analysis, but will continue enrollment in the safety portion and a second Phase III trial to meet requirements for additional safety data...

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