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Azur Pharma Inc. Release; 2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management  
12/19/2011 10:50:06 AM

DUBLIN, Dec. 19, 2011 /PRNewswire/ -- A panel of experts has recommended changes to the guidelines used to determine treatment via intrathecal administration for patients suffering from severe chronic pain. The 2011 Polyanalgesic Consensus Conference (PACC) brought together a group of national leaders in chronic pain management for the purpose of updating their current algorithm to standardize decision-making among providers and improving the technical quality of care in chronic pain.

The 2011 PACC guidelines for management of nociceptive and neuropathic chronic pain by intrathecal drug delivery recommended ziconotide, among other drugs, as a first-line intrathecal treatment. The panel recognized that ziconotide should be titrated in a low and slow manner. Ziconotide was also recommended by the 2011 group as the preferred option for intrathecal administration compared to opioids when there is a concern for recurrent granuloma. [please see important safety information and product indication at the end of this release]

The expert panel recommendation was based on an extensive literature search and an expansive survey with more than 15,000 clinicians worldwide since the last update in 2007. The panel also reviewed changes in the FDA status of medications and their combined clinical expertise to inform their recommendations

"The Consensus Conference was convened to review the importance of drug selection in patient outcomes; to review issues concerning granuloma detection, prevention and treatment; to consider trialing methods and candidates and to consider best practices to reduce morbidity and mortality," said Tim Deer, MD, president and CEO, The Center for Pain Relief and Clinical Professor of Anesthesiology, West Virginia University School of Medicine, Charleston, WV.

The expert panel of 29 clinicians and the faculty of the North American Neuromodulation Society was convened by Tim Deer, MD, Joshua Prager, MD, MS, Center for the Rehabilitation of Pain Syndromes (CRPS) at UCLA Medical Center, Los Angeles, CA; and Robert Levy, MD, PhD, Northwestern, University, Feinberg School of Medicine, Chicago, IL. The results were presented during the North American Neuromodulation Society Annual Meeting, Dec. 8-11, in Las Vegas, NV.

"The importance of selecting the best drug options for intraspinal drug delivery to treat those in severe pain cannot be understated," added Deer. "We must continue to keep all our colleagues informed of the best treatment practices in pain management and routinely evaluate treatments and patient data. Best clinical practices, experience, data and overall better patient outcomes will remain at the core of the Polyanalgesic Consensus Conference."

About the 2011 Polyanalgesic Consensus Conference
The PACC is an expert panel of leading pain management physicians from throughout the United States who meet periodically to evaluate the efficiency of various treatments. The panel is supported by an unrestricted medical education grant. Members of the 2011 Panel Include:

Christopher Bernards, MD
Virginia Mason Medical Center,
Seattle, WA

Allen Burton, MD
Houston Pain Associates,
Houston, TX

Eric Buchser, MD
Center for Neuromodulation EHC,
Morges, Switzerland

David Caraway, MD, PhD
Center for Pain Relief
Charleston, WV

Michael Cousins, MD
Royal North Shore Hospital
Sydney, Australia

Jose DeAndres, MD, PhD, FIPP, EDRA
Valencia University General Hospital
Valencia, Spain

Sudhir Diwan, MD, MS
Cornell Weill
New York, NY

Stuart DuPen, MD
Overlake Medical Center Pain Management Clinic
Bellevue, WA

Michael A. Erdeck, MD
Johns Hopkins University
Baltimore, MD

Eric Grigsby, MD
Napa Pain Institute
Napa, CA

Marc A. Huntoon, MD
Vanderbilt University Medical Center
Nashville, TN

Philip S. Kim, MD
Center for Interventional Pain & Spine
Newark, DC

Krishna Kumar, MB, BS
Regina Qu'appelle Health Region
Regina, Saskatchewan

Michael Leong, MD
Chief at Stanford Pain Management Center
Stanford, CA

Liong Liem, MD, FIPP
St. Antonius Hospital
Utrecht, Netherlands

Gladstone McDowell II, MD
CEO/Medical Director, Integrated Pain Solutions
Columbus, OH

Nagy Mekhail, MD, PhD
Cleveland Clinic
Cleveland, OH

Sunil Panchal, MD
National Institute of Pain
Tampa, FL

James P. Rathmell, MD
Harvard Medical School
Boston, MA

Richard Rauck, MD, FIPP
Carolinas Pain Institute
Winston-Salem, NC

Peter Staats, MD, MBA
Metzer Staats Pain Management
Manalapan, NJ

Michael Saulino, MD, PhD
MossRehab
Voorhees, NJ

B. Todd Sitzman, MD, MPH
Advanced Pain Therapy, PLLC
Hattiesburg, MS

Michael Stanton-Hicks, MD
Center for Neurological Restoration, Cleveland Clinic
Cleveland, OH

Lisa Jo Stearns, MD
Center for Pain and Supportive Care
Scottsdale, AZ

Mark Steven Wallace, MD
University of California, San Diego Health System
San Diego, CA

K. Dean Willis, MD
Alabama Pain Center and Alabama Fibromyalgia Center
Huntsville, AL

William O. Witt, MD
University of Kentucky
Lexington, KY

Tony Yaksh, PhD
University of California, San Diego
San Diego, CA

About Azur Pharma
Azur Pharma is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products. (website: www.azurpharma.com)

About PRIALT(R) (ziconotide intrathecal infusion)
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 populations, including patients with pain related to failed back surgery, cancer, AIDS, and non-malignant causes.

Safety Profile
PRIALT has been evaluated as an IT infusion in more than 1,200 patients participating in chronic pain trials.

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.

Because PRIALT is a non-opioid, it does not react with opiate receptors and does not potentiate opiate-induced respiratory depression. Dosage titration can be tailored to patient needs without the risk of dependency or tolerance. The most frequently reported adverse events (greater-than-or-equal-to 25%) in clinical trials (N=1,254) were dizziness, nausea, confusional state and nystagmus. In the slow titration PRIALT study (N=220), asthenia, ataxia, CK increase, abnormal gait, confusion, diarrhea, dizziness, headache, memory impairment, nausea, somnolence, and vomiting were the most commonly reported AEs in the PRIALT group (³10%).

Medical Information
Information about PRIALT, including prescribing information and comprehensive support services, is available through a toll-free number, 1-888-PRIALT-1, and at http://www.PRIALT.com.

Please see full prescribing information including boxed warning at http://www.prialt.com/PDF/product_information.pdf

PRIALT(R) is a registered trademark and is a trademark of Elan Pharmaceuticals Inc. SynchroMed(R) is a registered trademark of Medtronic, Inc. CADD-Micro(R) is a registered trademark of the Smiths Medical family of companies.

Please see accompanying full prescribing information.

Contact:
Matt Wiley
Azur Pharma, Inc.
(215) 832-3753
matt.wiley@azurpharma.com

SOURCE Azur Pharma, Inc.


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