Durect Corporation reported the preliminary results of its Phase II clinical trial for its lead product, a 3-month continuous infusion subcutaneous implant for the treatment of chronic pain. The product, previously referred to as DUROS sufentanil, has been given the product name Chronogesic.
Preliminary results from the Phase II study showed that patients had clinically significant improvement in pain control and had reductions in some opioid side effects when treated with Chronogesic compared to the patients' previous opioid therapies. A full analysis of the Phase II data is currently underway and the complete findings will be available upon completion of Phase II study analysis.
This Phase II clinical trial was designed to determine the dose conversion strategy from other approved opioid medications to Chronogesic, and to evaluate the safety and efficacy of the Chronogesic therapy. The study enrolled adults ranging in age from 26 to 68 at 9 clinical sites. The study included patients whose chronic pain is stable and opioid responsive (daily opioid requirements of 1001,000 mg of oral morphine equivalents) and results from a variety of malignant and non-malignant causes. The blinded randomized crossover portion of the study was designed to address conversion from other opioids to Chronogesic, followed by an open-label portion where Chronogesic was implanted in patients for up to 6 weeks, and safety and efficacy assessed.
"We believe Chronogesic, which is designed to provide 3 months of continuous relief for chronic pain patients, represents a significant advancement in pain therapy and adds a valuable tool to the treatment options for chronic pain patients," stated Dr. Dennis Fisher, Vice President of Medical Affairs and Medical Director of Durect. "The preliminary outcomes from this study are consistent with the positive reaction of physicians about our product, as demonstrated by completion of patient enrollment for this study in less than three months and three months ahead of schedule. Most of the physicians from our Phase II trial and numerous investigators from around the world have expressed strong interest in participating in our upcoming Phase III trials."