Durect Corporation has completed the clinical portion of its Phase II clinical trial for the company's lead product, DUROS sufentanil. Over 50 patients at 9 clinical centers completed the clinical portion of the study more than 3 months ahead of schedule.
DUROS sufentanil is designed to deliver sufentanil on a continuous basis for 3 months for the treatment of chronic pain. Sufentanil is a FDA approved opioid that is currently used in hospitals as an anesthetic. Chronic pain is a significant problem associated with chronic diseases, including cancer and various neurological and skeletal disorders. DUROS sufentanil is intended for patients whose chronic pain is stable, opioid responsive and results from a variety of malignant and non-malignant causes. Annual sales of opioids for the treatment of chronic pain are in excess of $1 billion.
This Phase II trial was designed to determine the dose conversion from other approved opioid medications to DUROS sufentanil. Durect utilised an advisory panel of leading clinical physicians and experts in the field of chronic pain to develop the protocol for the Phase II trial. The trial evaluated the safety and efficacy of continuous dose of sufentanil via a subcutaneously implanted DUROS sufentanil system in stable opioid responsive chronic pain patients. The information on relative potency and conversion charts collected in this study will be used in Phase III trials designed to demonstrate the safety and efficacy of the DUROS sufentanil product.
"We are very pleased at the progress that we have made with our Phase II trial for DUROS sufentanil. The accelerated pace exceeds our expectations," said James E. Brown, President and CEO of Durect. "We believe that this reflects the potential benefits of this product to both patients and physicians. We believe DUROS sufentanil has the potential to be a more convenient, patient-friendly product that may provide an alternative to current therapies for the long term treatment of stable and opioid responsive chronic pain."