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2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management
Date:12/19/2011

On December 28, 2004, the FDA approved PRIALT for the management of severe chronic pain in patients for whom IT therapy is warranted, and who are intolerant of or refractory to other treatments, such as systemic analgesics, adjunctive therapies, or IT morphine. PRIALT is approved for use only in the Medtronic SynchroMed(R) EL, SynchroMed(R) II Infusion System and the CADD-Micro(R) ambulatory infusion pump.

Mechanism of Action
PRIALT is in a class of non-opioid analgesics known as N-type calcium channel blockers (NCCBs). PRIALT is the synthetic equivalent of a naturally-occurring conopeptide found in a marine snail known as Conus magus. Research in animals suggests that the mechanism of action of PRIALT works by targeting and blocking N-type calcium channels on nerves in the spinal cord that ordinarily transmit pain signals.

Dosing and Administration
PRIALT is administered through microinfusion devices (pumps) delivering the drug into the fluid surrounding the spinal cord. Typically, these pumps are implantable, programmable, variable rate microinfusion devices, but external pumps may be used for initial or shorter-term treatment. The current dosing and titration schedule for PRIALT was optimized based on the final phase III pivotal trial. In the slow titration study, the initial dosing was lowered and the rate of titration was reduced in both frequency and dosage increments compared with previous clinical trials. Treatment should be initiated at a delivery rate of 2.4 mcg/d (0.1 mcg/h) or less. Titration increments should be 2.4 mcg/d or less, and increases should be made 1, 2, or no more than 3 times per week. FDA approval of PRIALT was based on the treatment of more than 1,200 patients included in the 3 phase III trials, which evaluated the efficacy and safety of PRIALT in patients with severe chronic pain that was not adequately managed with a regimen of systemic and/or IT analgesic and other drugs. These trials involved a variety of patient
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SOURCE Azur Pharma, Inc.
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