Jiangsu Yanshen found liable for producing and selling inferior quality products

September 06, 2015

Stephen J. Farr, Ph.D., President and Chief Operating Officer said, "With the completion of enrollment in our Phase 3 safety study, we believe ZX002 is on track to be the first potential single-entity, controlled-release hydrocodone formulation. Most marketed hydrocodone products contain acetaminophen, an analgesic which can cause liver toxicity at high doses over time. ZX002 is not combined with any other analgesic, and may be suitable for both patients who are using immediate-release opioid products on a chronic basis and patients already using extended-release opioids."

The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. Chronic pain can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the United States, generating $3.1 billion in U.S. sales during the 12 months ended June 2010 (Wolters Kluwer Pharma Solutions, Source?: PHAST Retail). Most of these products contain the analgesic combination ingredient acetaminophen. When used in high dosages over time, acetaminophen can cause liver toxicity.

SOURCE Zogenix, Inc.