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Cephalon Files Supplemental NDA for Sugar-Free Formulation of ACTIQ
Posted on 2004-12-03 15:29:00
Cephalon, Inc. has filed a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration requesting marketing approval of a sugar-free formulation of ACTIQ (oral transmucosal fentanyl citrate.The currently-marketed formulation of ACTIQ is approved by the FDA for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. If approved, the sugar-free formulation of ACTIQ will be marketed for the same indication.ìWe developed this new formulation to meet both physician and patient demand for a sugar-free product,î said Dr. Paul Blake, Senior Vice President of Clinical Research and Regulatory Affairs. ìWe believe the new formulation will meet those needs and we expect that, once approved, it will be well received.îThe electronic application was filed on the basis of positive data from a study of healthy volunteers demonstrating that the sugar-free formulation is bioequivalent to the current formulation. Once approved, the new formulation will be available in all dosage strengths of ACTIQ (200/400/600/800/1200/1600 mcg), and will be sold in the U.S. market instead of the current formulation.The FDAís targeted review period for sNDAs of this type is four months; Cephalon anticipates final FDA approval by the end of the second quarter of 2005.
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