SAN DIEGO, March 17 /PRNewswire/ -- 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(R) technology, offers a unique controlled-release profile which utilizes both immediate release and extended release properties designed to enable twice daily dosing.
ZX002 Phase 3 Clinical Trial Design
This Phase 3 efficacy trial for ZX002 is designed to enroll approximately 600 patients with chronic low back pain. The trial is a US-based multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZX002. For further information regarding this study contact: www.clinicaltrials.gov and reference NCT01081912.
About Elan Drug Technologies and SODAS(R) Technology
Elan Drug Technologies (EDT), a leader in drug delivery, is a business unit of Elan Corporation, plc . EDT developed the controlled release formulation of hydrocodone, using one of its Oral Controlled Release Technologies, the SODAS(R) (Spheroidal Oral Drug Absorption System) technology, which has been accepted by regulatory authorities worldwide including approvals for SODAS-based products in the US for Avinza(R), Ritalin LA(R) and Focalin(R) XR. A number of other compounds are in late stage development utilizing Elan Drug Technologies SODAS(R) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions. More information is available at www.elandrugtechnologies.com.
CONTACT: Investors, Ann Rhoads, +1-858-436-8583, ir@zogenix.com, or Media,
Catherine O'Connor, +1-858-436-3374, coconnor@zogenix.com, both of Zogenix,
Inc.
Web site: http://www.zogenix.com/
http://www.elandrugtechnologies.com/
