Cephalon Inc announced that manufacture of ACTIQ (oral transmucosal fentanyl citrate) [C-II] for the U.S. market has been transferred from a contract manufacturer to Cephalon's recently expanded facility in Salt Lake City, Utah. The move follows the February 19, 2003 approval by the U.S. Food and Drug Administration of a new compressed powder formulation of ACTIQ for the management of breakthrough pain in cancer patients who are tolerant to opioid therapy. This formulation, which the Salt Lake City facility has manufactured for the European market since November 2000, replaces the current sugar melt formulation sold in the United States.
"The recent expansion of our Salt Lake City manufacturing capacity allows Cephalon to satisfy increasing demand for ACTIQ, while enabling us to provide the compressed powder formulation in all of our markets," said Robert Urban, Vice President for Technical Operations. "Our new production lines have been operational for several weeks and we look forward to completing this transition."
ACTIQ is the first and only drug approved for the management of breakthrough pain. ACTIQ is indicated for patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ACTIQ utilizes a novel oral transmucosal system (OTS) that delivers the potent pain reliever fentanyl via a soluble lozenge that is attached to a handle and dissolves as patients move the unit along the inside of their cheeks. Typical side effects include somnolence, nausea, vomiting, and dizziness. The greatest risk from improper use of ACTIQ, as with all opioid-based products, is the potential for respiratory depression, which can be life threatening.