Navigation Links
2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management

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
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:

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

Please see full prescribing information including boxed warning at

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.

Matt Wiley
Azur Pharma, Inc.
(215) 832-3753


SOURCE Azur Pharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Consensus Document Outlines Practical Steps for Reducing Gastrointestinal Risks of Antiplatelet and NSAID Use
2. Agendias Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus Recommendations
3. Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen International Consensus Meeting on the Primary Treatment of Early Breast Cancer
4. Boston Scientific Second Quarter Results Exceed Consensus Sales and EPS; Full-Year Guidance Raised
5. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
6. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
7. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
10. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
11. Tezampanel, TorreyPines Therapeutics Lead Compound, Reduced Muscle Spasticity and Rigidity in Preclinical Study Conducted at University of California, San Diego
Post Your Comments:
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., ... vaccine design, and immune-engineering today announced the launch ... the development of personalized therapeutic cancer vaccines. EpiVax ... provided exclusive access to enabling technologies to the ... MBA will lead EpiVax Oncology as Chief Executive ...
(Date:9/22/2017)... 22, 2017 AVACEN Medical (AVACEN) announced that ... successfully helping those with the widespread pain associated with ... Amanda in Essex, England commented, ... hair, experiencing no sleep at all, tremendous pain, with ... cannot recommend [the AVACEN 100] enough, how this has ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 /PRNewswire/ ... and OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... a strategic hub service that expedites and streamlines patient ... spirometer, Spiro PD 2.0, and wellness management services.  ... a medical device used to measure lung function for ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th ... Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, ... The fun run is geared towards children of all ages; it is a non-competitive, ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
(Date:10/12/2017)... , ... October 12, 2017 , ... Planet Fitness, one ... U.S., announced today its plans to open a flagship location in Covington, LA at ... former Rooms To Go store next to Office Depot in the Holiday Square shopping ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... ... 2017 , ... Leading pediatric oncology experts at Children’s National Health System ... Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of ...
Breaking Medicine News(10 mins):