Durect has presented positive results from a 60 patient Phase IIb clinical trial of Posidur, a proprietary product under development for the treatment of post-surgical pain. Top line results from this study of patients undergoing arthroscopic shoulder surgery showed a consistent reduction of pain scores in parallel with a reduction of opioid use in favor of Posidur versus placebo.
These reductions were not statistically significant given the size of the study. In addition, there was a comparable safety profile between the two groups in this study and Posidur appeared well tolerated.
The Posidur Phase IIb clinical trial was a double blind, multi-center, placebo controlled, parallel group trial in patients undergoing arthroscopic shoulder surgery. Eligible patients were randomly assigned to one of two treatment groups prior to surgery (Saber-Bupivicaine (Posidur) or Saber-Placebo). Supplemental rescue analgesia for post-operative shoulder pain in both treatment groups was provided if needed. The study was conducted at sites in Australia and New Zealand.
Posidur is a long-acting local anesthetic under development by Durect and Nycomed for the treatment of post-surgical pain. It is intended to be administered during surgery, where it continuously releases therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of uninterrupted local analgesia. Posidur’s performance is due to Durect’s patented Saber delivery system, an injectable, biodegradable drug delivery technology.
James Brown, president and CEO of Durect, said: “We are pleased that this study provides a consistent signal of the analgesic effectiveness of Posidur in an orthopedic surgical model. We look forward to commencing enrollment of the US Phase III program in the first quarter of 2010.”