"Single Entity" Controlled Release Version of Hydrocodone in the Works

An oral, controlled-release formulation of hydrocodone without acetaminophen will be the focus of a pivotal phase three clinical trial initiated by Zogenix, Inc.

The formulation, ZX002, is designed to treat moderate to severe pain in patients on daily routines of opioid therapy. ZX002 has a controlled-release profile and enables twice daily dosing.

Currently, there are no products available that feature only hydrocodone; nor are there hydrocodone-based formulations that are controlled-release. While hydrocodone is among the most widely prescribed drugs for chronic pain relief, it is typically available in formulations that contain acetaminophen, or other non-steroidal anti-inflammatory drugs, which can have serious side effects over time when used chronically.

According to Zogenix officials, the company believes the new formulation could provide significant benefits to patients and practicing physicians by allowing for less frequent dosing with a customized controlled-release profile. The new formulation will also allow physicians to prescribe higher doses of hydrocodone, as needed, since NSAIDs will not be included.

The trial is expected to enroll approximately 600 patients with chronic low back pain and will serve to evaluate the efficacy, safety and tolerability of ZX002.