Intrathecal ziconotide for refractory chronic pain.
OBJECTIVE
To describe the pharmacology, efficacy, and safety of ziconotide for treatment of severe chronic pain in patients who are candidates for intrathecal therapy.


METHODS
A PubMed/MEDLINE search (1966-June 2006) was conducted using the terms ziconotide, Prialt, and SNX-111. Manufacturer-provided data, the Food and Drug Administration medical review of ziconotide, and abstracts presented at American Pain Society meetings (2001-2006) were also reviewed.


METHODS
Human studies evaluating the efficacy and safety of ziconotide for the treatment of chronic pain were considered. Animal data were excluded.


RESULTS
Ziconotide is the first and only neuronal-type (N-type) calcium-channel blocker. Ziconotide must be administered intrathecally via continuous infusion. A programmable implanted variable-rate microinfusion device, or an external microinfusion device and catheter must be utilized. In double-blind, placebo-controlled studies, ziconotide significantly improved patient perception of pain from baseline to the end of the study periods, which ranged from 11 to 21 days. Patients enrolled in clinical trials were intolerant of or refractory to other treatment modalities. There have been no studies that directly compared ziconotide with other intrathecal or systemic analgesics. Key ziconotide-related adverse events are neuropsychiatric, including depression, cognitive impairment, and hallucinations; depressed levels of consciousness; and elevation of creatine kinase levels. Ziconotide is also associated with a risk of meningitis due to possible contamination of the microinfusion device.


CONCLUSIONS
Ziconotide is a therapeutic option for treatment of severe chronic pain in patients who have exhausted all other agents, including intrathecal morphine, and for whom the potential benefit outweighs the risks of serious neuropsychiatric adverse effects and of having an implanted device. Further studies are needed to determine the comparative efficacy of ziconotide and other pain therapies.
Lynch
Shalini S
SS
Department of Clinical Pharmacy, University of California, San Francisco, 94143, USA. lynchs@pharmacy.ucsf.edu
Cheng
Christine M
CM
Yee
Jennie L
JL
D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004347:Drug Interactions; D006801:Humans; D007278:Injections, Spinal; D010148:Intractable Pain / Q000188:drug therapy* / Q000378:metabolism; D020960:omega-Conotoxins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
D018712:Analgesics, Non-Narcotic; D002121:Calcium Channel Blockers; D020960:omega-Conotoxins; C078452:ziconotide