AUG 6, 2001 - (NewsRx.com & NewsRx.net) -- DURECT Corp. (DRRX) announced that improved pain control and reduced side effects, in comparison to conventional opioid therapies, are realized when opioids are delivered from a continuous infusion subcutaneous implant.
Preliminary results of a Phase II clinical trial involving a three-month implant for the treatment of chronic pain. The product, previously referred to as DUROS sufentanil, has been given the name ChronogesicTM. Results of the study were presented to pain clinicians from around the world at the 2nd World Congress of the World Institute of Pain held June 27-30, 2001, in Istanbul, Turkey.
The results 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.
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 nine clinical sites. The study included patients whose chronic pain was stable and opioid responsive (daily opioid requirements of 100-1,000 mg of oral morphine equivalents) and resulting 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 six weeks, and safety and efficacy assessed.
"We believe Chronogesic, which is designed to provide three 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, 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."
"These preliminary results support our belief that Chronogesic 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," stated James E. Brown, DURECT.