Pennsylvania-based Cephalon Inc., which makes its cancer-pain-relieving drug Actiq in Salt Lake City, said Wednesday it has filed with federal regulators an application for a sugar-free version of Actiq.
The new drug application with the U.S. Food and Drug Administration is for marketing approval of the new formulation.
The currently marketed version manages "breakthrough" pain in cancer patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The company said a study demonstrates that the sugar-free version is "bioequivalent" to the current one. The new formulation would be sold in the U.S. market instead of the current version, it said.
Cephalon expects final FDA approval by the end of the 2005 second quarter.
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