DURECT reported that PERSIST, the Phase 3 clinical trial for POSIMIR (SABER-Bupivacaine), did not meet its primary efficacy endpoint of reduction in pain on movement over the first 48 hours after surgery as compared to standard bupivacaine HCl. While results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance. POSIMIR is an investigational drug candidate being developed for the treatment of post-surgical pain.
"We are very surprised and disappointed by these results, which we will be trying to understand more fully over the coming weeks," said James E. Brown, President and CEO of DURECT Corporation. "We appreciate the efforts of the investigators and patients who participated in PERSIST, and we thank Sandoz for their support."
POSIMIR is an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours to provide up to three days of continuous pain relief after surgery. POSIMIR is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.