Elan Corporation, plc today announced that the U.S. Food and Drug Administration (FDA) has approved PRIALT(R) (ziconotide intrathecal infusion) for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or IT morphine. FDA approval of PRIALT was based on the treatment of more than 1,200 patients and three Phase III clinical trials, which evaluated the efficacy and safety of IT PRIALT in patients with severe chronic pain that was not adequately managed despite a regimen of systemic and/or IT analgesic and other drugs.
