Endo Pharmaceuticals Inc. said Monday an interim analysis of late-stage clinical data showed its cancer pain treatment candidate Rapinyl is effective, meeting both primary and secondary trial goals.
Rapinyl is an oral, fast-dissolving tablet of fentanyl designed to treat breakthrough cancer pain, or pain flares unable to be controlled by regular doses of pain medicines. Fentanyl is a narcotic opioid about 80 times more powerful than morphine which is used to treat severe pain.
Data on 61 patients showed Rapinyl met its main endpoint of reducing pain after 30 minutes, by a "statistically significant" margin. Furthermore, when comparing Rapinyl with placebo on mean pain intensity, Endo said Rapinyl showed a statistically significant difference after just 10 minutes.
Based on these results, Endo is halting enrollment in a portion of the clinical study, but will continue the safety arm. The company also is conducting a second Phase III trial to meet requirements for culling additional safety data.
Endo noted that although this planned interim analysis was only intended to determine effectiveness and not tolerability in patients, side effects were consistent with what is usually observed with other opioids, or pain drugs.
Chief Scientific Officer Dr. David Lee said in a press release that Endo may file a new drug application with the Food and Drug Administration based on these results. Endo expects to provide more updates on the status of the Rapinyl clinical development program early in 2008.
Endo licensed the exclusive rights to develop and market Rapinyl in North America from Sweden's Orexo AB. Endo Pharmaceuticals Inc. is a subsidiary of Endo Pharmaceuticals Holdings Inc.
Shares of Chadds Ford, Pa.-based Endo jumped 66 cents, or 2.4 percent, to $27.78 in morning trade.
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