Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen.  ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.  Hydrocodone is the most widely prescribed drug in the United States, but there are currently no products available with hydrocodone only, or with controlled-release formulations.  ZX002, which incorporates Elan's proprietary SODAS® technology, offers a unique controlled-release profile which utilizes both immediate release and extended release properties designed to enable twice daily dosing.

"We are pleased to be initiating this pivotal Phase 3 trial of ZX002 as the first single-entity, controlled-release hydrocodone formulation," said Cynthia Robinson, Ph.D., chief development officer of Zogenix.  "We believe this hydrocodone therapy could offer significant benefits to both the patient and the practicing physician by allowing for less frequent dosing with a customized controlled-release profile and the ability to titrate to higher hydrocodone doses than currently recommended for hydrocodone products burdened by combination formulations. Further, we believe ZX002 may offer patients an option for the treatment of their chronic pain that potentially avoids some of the serious side effects that can accompany chronic use of combination opioids that contain acetaminophen, or other non-steroidal anti-inflammatory drugs (NSAIDs)."