Elan Drug Technologies, a business unit of Elan Corporation, plc announced that Zogenix Inc, its licensee, has completed enrolment in its open-label Phase 3 study (Study 802) of ZX002, a novel, oral, single-entity, controlled-release formulation of hydrocodone. ZX002, which was developed using Elan Drug Technologies’ SODAS® technology, is being studied for the treatment of moderate to severe chronic pain in individuals who require around-the-clock opioid therapy for the control of pain. The goal of this 12-month study is to evaluate the long-term safety and tolerability of ZX002. Zogenix is concurrently running a pivotal Phase 3 efficacy study (Study 801) where initial top-line data is expected in the second half of 2011. At present there are no products available as single-entity, controlled-release formulations of hydrocodone in the United States. Using Elan Drug Technologies’ SODAS® technology, ZX002, offers a unique, controlled-release profile which utilises both immediate release and extended release properties designed to enable twice daily dosing.
Zogenix expects, pending positive Phase 3 clinical results, to submit an NDA for ZX002 with US Food and Drug Administration (FDA) by early 2012. The product would be manufactured in Elan Drug Technologies’ DEA approved site at Gainesville, Georgia in the US.