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Old 09-30-2007, 03:59 PM
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Sandel Sandel is offline
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Join Date: Oct 2006
Location: Western Canada
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Sandel Sandel is offline
Member
Sandel's Avatar
 
Join Date: Oct 2006
Location: Western Canada
Posts: 844
15 yr Member
Default just found this too..

New Pain Treatments
PRIALTŪ (ziconotide intrathecal infusion), developed by scientists at Elan, is in a class of non-opioid analgesics known as N-type calcium channel blockers. PRIALT is approved for use only in the Medtronic SynchroMed EL, SynchroMed II Infusion System and Simms Deltec Cadd Micro External Microinfusion Device and Catheter. PRIALT is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research suggests that PRIALT’s novel mechanism of action works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals. PRIALT is administered through appropriate programmable microinfusion pumps that can be implanted or external, and which release the drug into the fluid surrounding the spinal cord.

PRIALT has been evaluated as an IT infusion in more that 1,200 patients participating in chronic pain trials. The longest treatment duration to date is more than seven years. This combined number of patients represents the largest IT analgesic safety database ever compiled for any IT treatment, including 16 studies that were controlled and open-label studies.

Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.

The most frequently reported AEs associated with the drug in clinical trials were asthenia, nausea, vomiting, abnormal gait, ataxia, confusion, dizziness, memory impairment, nystagmus, abnormal vision, and urinary retention. It is recommended that PRIALT be administered intrathecally by or under the directiadministration and who is familiar with the drug and device labeling. PRIALT is not a substitute for opioids. If opiate withdrawal is required, patients must be withdrawn slowly from opiates when initiating therapy with PRIALT.on of a physician experienced in the technique of IT administration and who is familiar with the drug and device labeling. PRIALT is not a substitute for opioids. If opiate withdrawal is required, patients must be withdrawn slowly from opiates when initiating therapy with PRIALT.

Source:
http://www.elan.com/Images/ChronicPa..._tcm3-7762.pdf

>> Here is a trial done that explains ALOT:
http://www.medscape.com/viewarticle/510621_4

Last edited by Sandel; 09-30-2007 at 04:14 PM. Reason: added source
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