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Title: FDA Approves Prialt (Ziconotide Intrathecal Infusion) for Severe Chronic Pain

"FDA Approves Prialt (Ziconotide Intrathecal Infusion) for Severe Chronic Pain"

Prialt is Approved for Use Only in The Medtronic SynchroMed® EL, SynchroMed® II Infusion System and Simms Deltec Cadd Micro(R) External Microinfusion Device and Catheter NEW YORK, NY -- December 29, 2004 -- This is a MultiVu special report. There is a new alternative for patients who suffer from severe chronic pain who require intrathecal therapy that cannot be relieved by morphine and other potent pain drugs. The FDA just approved a new analgesic called Prialt, or ziconotide intrathecal infusion. Research suggests that Prialt works by targeting and blocking calcium channels on nerves that ordinarily transmit pain signals. Prialt is administered through an appropriate implanted programmable pump that releases the drug into the fluid surrounding the spinal cord. In clinical trials, it helped alleviate pain in most patients over the long term. Dr. Michael Leong, of Stanford University and the Bay Area Pain Center, explains: "Prialt, the man-made equivalent of a conopeptide found in the venom of the Conus magus snail, has been shown in recent clinical studies to be effective in reducing pain for patients that had failed all other therapies. More impressively for me, many of these patients decreased the amount of narcotic that they took for their chronic pain." Severe chronic pain lasts longer than six months and has multiple causes, including failed back surgery, injury, accident, cancer, AIDS, and other nervous system disorders. For more information on severe chronic pain or Prialt, consult your physician or visit http://www.prialt.com. Fair Balance: 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 adverse events 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 (IT) by or under the direction 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: Elan

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