Hospice news

Abstract

In late December 2004, the Food and Drug Administration (FDA) approved ziconotide intrathecal (IT) infusion (Prialt®), Elan Corporation, Dublin, Ireland), for the management of severe pain in patients for whom IT therapy is warranted and who are intolerant or refractory to other treatment. Ziconotide is the first approved drug in a new class of nonopioid analgesics called N-type calcium channel blockers (NCCBs). A synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus, ziconotide selectively blocks calcium channels on nerves that ordinarily transmit pain signals to the brain. FDA approval was based on treatment of more than 1,200 patients and three phase-III clinical trials that evaluated its safety and efficacy in patients with severe chronic pain. The trials included a variety of subjects, including patients with pain related to failed back surgery, cancer, AIDS, and nonmalignant causes. Adverse side effects were mild to moderate and included dizziness, ataxia, confusion, and abnormal gait. For a fact sheet and prescribing information, visit Elan’s Web site at www.prialt.com. (Source: Medscape Medical News, January 15, 2005.)