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

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® 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: 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™ DosePro™ (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

About Elan Drug Technologies and SODAS® Technology

Elan Drug Technologies (EDT), a leader in drug delivery, is a business unit of Elan Corporation, plc ( 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

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.

Back to top



SOURCE Zogenix, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Chimerix Initiates Phase 2 Study of CMX001 in Stem Cell Transplant Recipients Seropositive for Cytomegalovirus
2. ISIS Initiates Phase 1 Clinical Trial of ISIS-SOD1Rx in Patients With ALS
3. Kinex Pharmaceuticals Initiates a Phase 2 Clinical Trial of KX2-391 in Patients with Prostate Cancer
4. QRxPharma Initiates Second Pivotal Phase 3 Study of MoxDuo(TM)IR Dual-Opioid(TM) for NDA Submission
5. Daiichi Sankyo Initiates Largest Single, Double-Blind, Randomized, Phase III Trial for Treatment and Prevention of Recurrent Venous Thromboembolism
6. Celsis Initiates Patent Infringement Action Against XenoTech and Sekisui
7. Romark Initiates Clinical Trial of Alinia for Treatment of Influenza
8. Conatus Pharmaceuticals Initiates Phase II Clinical Trial in Combination With Pegylated Interferon and Ribavirin for the Treatment of Hepatitis C Virus (HCV)
9. ChemoCentryx Initiates Clinical Trial of CCX168, A Novel Small Molecule C5aR Antagonist for the Treatment of Inflammatory and Autoimmune Diseases
10. Naurex Inc. Initiates Phase I Clinical Trial of its Novel Mechanism NMDA Modulator GLYX-13 in Treatment-Resistant Depression
11. Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
Post Your Comments:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
(Date:6/24/2016)...   Bay Area Lyme Foundation , collaborating ... for Tick Borne Illness , Harvard Medical School ... Medicine, University of California, Berkeley, and the Veterans ... finalists of Lyme Innovation , the first ... scientists, clinicians, researchers, entrepreneurs, and investors from several ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... the only authorized OSHA Training Institute Education Center headquartered in Northern California, has ... workers from extreme heat at their worksites. Employers with workers exposed to ...
(Date:6/27/2016)... Aliso Viejo, California (PRWEB) , ... June 27, 2016 , ... ... that are fully customizable inside of Final Cut Pro X," said Christina Austin - ... with another unique style. Final Cut Pro X users can now reveal ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... health professionals, announced today its affiliation with Tennessee Counseling Association. This ... the network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. ...
(Date:6/27/2016)... ... June 27, 2016 , ... ePAY ... partnership with Connance, a healthcare industry leader providing predictive analytics to optimize ... combine to provide health systems, hospitals and ambulatory surgical centers with dramatic ...
(Date:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
Breaking Medicine News(10 mins):