Hydrocodone capsules soon to be available in 10MG, 20MG, 30MG, 40MG and 50MG capsules.
ZOGENIX is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain.Their lead product candidate, Zohydro, is a novel, oral, single-entity extended-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zohydro utilizes Elan Pharma International Limited’s proprietary Spheroidal Oral Drug Absorption System, or SODAS® Technology, which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations. Most marketed hydrocodone products contain the analgesic combination ingredient acetaminophen, which if taken in high quantities over time can cause liver toxicity. Zohydro, if approved, may represent the first available extended-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. As a result, we believe Zohydro could generate sales from both patients who are using immediate-release opioid products on a chronic basis and patients already using extended-release opioids. We initiated the Phase 3 clinical development program for Zohydro in March 2010.
We believe that Zohydro, if approved, may provide patients and physicians with the following benefits when compared to existing opioid pain medications:
- Single-entity hydrocodone
- Twice daily dosing provides true around-the-clock relief
- Easier adherence/greater patient convenience
- Another opioid option for chronic medication rotation
About Chronic Pain
Pain is a worldwide problem with serious health and economic consequences. 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 may be defined as pain that lasts beyond the healing of an injury or that persists beyond three months. Common types of chronic pain include lower back pain, arthritis, headache and face and jaw pain. While mild pain does not typically stop an individual from participating in his or her daily activities, moderate pain may prevent an individual from participating in his or her daily activities and severe pain typically stops an individual from participating in his or her daily activities and induces a patient to exhibit pain avoidance behaviors.
- Zohydro Phase 3 Clinical Development Program
To further assess the safety and tolerability of Zohydro as a chronic pain therapy, we have also initiated an open-label Phase 3 trial in opioid-experienced adult subjects with any indication appropriate for continuous, around-the-clock opioid therapy for an extended period of time (Study 802). The goal of this trial is to evaluate the safety and tolerability of Zoydro for up to 12 months of treatment.
- Prior Clinical Development of Zohydro
Phase 1 and Phase 2 Clinical Development. In single and multiple dose pharmacokinetic evaluations, ZX002 demonstrated a consistent, controlled-release profile, dose-proportional pharmacokinetics and an acceptable safety profile.
Zohydro has also been evaluated in two separate Phase 2 pain studies. We believe this efficacy and safety information is useful in establishing proof-of-concept for Zohydro. In both Phase 2 studies, patients experienced mild to moderate adverse events, such as dizziness, sedation, nausea, vomiting and constipation, which are similar to the reported effects of opioids currently prescribed for chronic pain.
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