CUPERTINO, Calif., Jan. 5, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today top-line results from the U.S. pivotal Phase III clinical study for POSIDUR® known as BESST (Bupivacaine Effectiveness and Safety in SABER trial). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER™ technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. BESST was conducted to measure the safety and efficacy of POSIDUR versus placebo in one abdominal surgical procedure and versus an active comparator (injections of standard bupivacaine) in two other abdominal surgical procedures. The co-primary endpoints were pain intensity as well as the use of opioid analgesics over the first 3 days following surgery.
While the results trended positive for both pain reduction and reduction of supplemental opioid use in the first three days after surgery, they did not reach statistical significance. There were no signs of systemic safety issues, although local site reactions were observed more frequently in the POSIDUR and SABER-Placebo groups than in the active comparator groups. A full safety assessment is not yet available.
"POSIDUR continues to appear to be safe based on our preliminary review of the BESST data, which also suggests a reduction in pain associated with surgical incision in all three cohorts," stated James E. Brown, President and CEO. "After a complete analysis of the BESST data and preparation of integrated safety and efficacy reports combining our previous well controlled studies, we intend to hold a pre-NDA meeting with the FDA."
"Hospira looks forward to DURECT's conversations with the FDA, and we su
|SOURCE DURECT Corporation|
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