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Azur Pharma Announces the Signing of a Definitive Agreement to Acquire PRIALT(R) From Elan
Date:3/11/2010

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 populations, including patients with pain related to failed back surgery, cancer, AIDS, and non-malignant causes.

Safety Profile


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