Zogenix Initiates Pivotal Phase 3 Clinical Trial for Novel Formulation of Oral Controlled-Release Hydrocodone

Wednesday, March 17, 2010 Research News
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SAN DIEGO, March 17 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)."

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 Zogenix

Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company is commercially focused on SUMAVEL(TM) DosePro(TM) (sumatriptan injection) needle-free delivery system, which launched in January 2010. The company's pipeline includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, which entered Phase 3 clinical trials in March 2010. Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, please visit www.zogenix.com.

About Elan Drug Technologies and SODAS® Technology

Elan Drug Technologies (EDT), a leader in drug delivery, is a business unit of Elan Corporation, plc (NYSE: ELN). EDT developed the controlled release formulation of hydrocodone, using one of its Oral Controlled Release Technologies, the SODAS® (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®, Ritalin LA® and Focalin® XR. A number of other compounds are in late stage development utilizing Elan Drug Technologies SODAS® 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.

SODAS is a registered trademark of Elan Pharma International Ltd

AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.

FOCALIN and RITALIN LA are registered trademarks of Novartis AG

SOURCE Zogenix, Inc.


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