DURECT Corporation (Nasdaq: DRRX) announced today that its licensee, King Pharmaceuticals (NYSE: KG), has begun a Phase IIb clinical trial to evaluate ELADUR™ (TRANSDUR™-Bupivacaine) for the treatment of chronic low back pain. ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application. This Phase IIb trial is a 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ELADUR in patients with chronic low back pain. King expects to enroll approximately 260 patients in the study.
"We're pleased that King is developing ELADUR for chronic low back pain, a clinical indication for which currently marketed anesthetic patches are not approved," stated James E. Brown, President and CEO of DURECT Corporation. "If approved for chronic low back pain, we believe that this novel bupivacaine patch has the potential to compete strongly in the large market for topical pain products given its patient friendly design and extended duration of therapeutic use."
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