Non-Narcotic Ziconotide Intrathecal Infusion (Prialt) for Severe
Chronic Pain
On Dec. 28, the FDA approved ziconotide intrathecal (IT)
infusion (Prialt, made by Elan Corporation, plc), for the management of severe chronic
pain in patients for whom IT therapy is warranted, and who are intolerant or refractory to
other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.
The non-narcotic agent is the synthetic equivalent of a naturally occurring
conopeptide found in a marine snail known as Conus magus, and is thought to work by
blocking N-type calcium channels on nerves that transmit pain signals.
The approval was based on the results of three phase 3 clinical trials showing
that ziconotide IT significantly reduced chronic pain in a variety of opioid-resistant
patient populations with neuropathic pain and pain related to cancer and AIDS.
Adverse events were mild to moderate in intensity and included dizziness,
ataxia, confusion, and abnormal gait.
Ziconotide IT is approved for use only in the Medtronic SynchroMed EL, SynchroMed
II Infusion System, and Simms Deltec Cadd Micro External Microinfusion Device and
Catheter.
