Healthcare Industry News: i-STAT
News Release - October 31, 2007
Polyanalgesic Consensus Panel's New Treatment Guidelines Via Intraspinal Infusion for Severe Chronic PainUpdated Algorithm Includes PRIALT(R) (ziconotide intrathecal infusion) as a First-Line Intraspinal Infusion Alternative to Opioid Medications
CHARLESTON, W.Va., Oct. 31 (HSMN NewsFeed) -- The 2007 Polyanalgesic Consensus Panel (PCP) -- a group of leading national pain management physicians from the United States and abroad -- has updated their intraspinal pain treatment guidelines and recommendations. The findings were released this month in Neuromodulation, a neurology and pain publication for physicians. The panel of pain experts revised the guidelines used to determine treatment via intraspinal infusion for patients suffering from severe chronic pain. The updated algorithm includes PRIALT (Elan Corp.) as a first-line alternative for intraspinal infusion to the opioids morphine and hydromorphone
"We did an extensive review of the literature that has been performed and the consensus was the data was very supportive that PRIALT should be considered a first line drug -- one of the first lines for intraspinal infusion you would use for a patient with chronic, severe or moderate pain," said Timothy Deer, MD of the Center for Pain Relief in Charleston, W.V. The group of experts was led by Deer and Samuel Hassenbusch, MD, PhD, of the University of Texas M.D. Anderson Cancer Center in Houston. [Please see important safety information for PRIALT].
In addition, the panel looked at safety as one of the real landmarks of which drugs to put in the algorithm, recognizing patient safety should always come first above helping the pain, added Deer. "Our consensus demonstrates the evidence is fairly strong in support of PRIALT safety and efficacy as a first-line intraspinal infusion treatment option for chronic pain."
In making their new recommendations, the panel reviewed data published since its last meeting in 2003, as well as newly approved drugs and the clinical treatment experience of the consensus panel members. PRIALT was approved by the FDA in 2004 and is a non-narcotic synthetic based conopeptide found in the Conus magus marine snail. It is an important addition to the list of options physicians have to treat severe chronic pain. Unlike intraspinal opioids, PRIALT is not known to be associated with granuloma formation, which means physicians and patients alike don't have to stop therapy and evaluate the need for catheter removal and replacement, according to Dr. Deer.
"The issue of chronic pain impacts the lives of one in four Americans," said Will Rowe, executive director of the American Pain Foundation. "People with chronic pain have different responses to the same medicines. What works for one, might not work for another. We support the development and availability of treatment options for people affected by pain and are very pleased that the Polyanalgesic Panel is elevating ziconotide to a first-line intraspinal infusion pain treatment option for patients and physicians to consider." [Please see important safety information for PRIALT].
The panel also recommends a slow dosage titration of PRIALT from 0.5 to 2.4 micrograms per day starting dosage range, with a maximum of 19.2 micrograms per day, to help reduce the risk of side effects.
According to Dr. Deer, the rapidly changing landscape of intraspinal drug delivery treatments necessitates periodic update of the guidelines so physicians can make informed treatment decisions that will most benefit their patients.
The original guidelines were published in 2000 in the peer reviewed Journal of Pain and Symptom Management. The guidelines were updated in 2003 and the panel's recommendations published the following year in the same journal. In previous years, the panel determined that preclinical and clinical trial data should include evidence of safety, efficacy, stability and compatibility with drug delivery systems, and, in the case of drug combinations, drug-drug stability.
Please see PRIALT full prescribing information at the end of this release.
About the Polyanalgesic Consensus Panel
The PCP is an interdisciplinary expert panel of leading pain management physicians from throughout the United States and abroad who meet periodically to evaluate the efficiency of various pain treatments. Authors of the 2007 Consensus Guidelines include
-- Timothy R. Deer, MD (The Center for Pain Relief, Charleston, WV)
-- Samuel Hassenbusch, MD (UT M.D. Anderson Cancer Ctr., Houston, TX)
-- Allen W. Burton, MD (UT M.D. Anderson Cancer Ctr., Houston, TX)
-- Stuart DuPen, MD (Overlake Medical Center Pain Medicine Clinic, Bellevue, WA)
-- Michael A. Erdek, MD (Johns Hopkins University, Baltimore, MD)
-- Kenneth A. Follett, MD (University of Nebraska Medical Center, Omaha, NE)
-- Philip S. Kim, MD (Center for Pain Medicine, Wilmington, DE)
-- Marc A. Huntoon, MD (Mayo Clinic, Rochester, NY)
-- Robert M. Levy, MD, PhD (Northwestern University, Chicago, IL)
-- Joshua P. Prager, MD, MS (Ctr. For Rehabilitation of Pain Syndromes, Los Angeles, CA)
-- Michael Saulino, MD, PhD (Moss Rehab Thomas Jefferson Univ. Elkins Parks, PA)
-- B. Todd Sitzman, MD, MPH (Advanced Pain Therapy, Forrest General Cancer Ctr., Hattiesburg, MS)
-- K. Dean Willis, MD (Alabama Pain Center, Huntsville, AL)
-- David Caraway, MD, PhD (The Center for Pain Relief Tri-STATe, Huntington, WV)
-- James C. Eisenach, MD (Wake Forest University School of Medicine, Winston-Salem, NC)
-- Eric Grigsby, MD (Spectrum Care Pain Treatment Ctr., Napa, CA)
-- Elliot Krames, MD, DABPM (Pacific Pain Treatment Centers, San Francisco, CA)
-- Gladstone C. McDowell, II, MD (Integrated Pain Solutions, Columbus, OH)
-- Sunil J. Panchal, MD (COPE Foundation, Tampa, FL)
-- Peter S. Staats, MD, MBA (Premier Pain/American Pain Medicine, Colts Neck, NJ)
-- Michael Stanton-Hicks, MD (Cleveland Clinic, Cleveland, OH)
-- Richard L. Rauck, MD (The Center for Clinical Research, Winston-Salem, NC)
-- James Rathmell, MD (MGH Pain Center, Boston, MA)
-- Lisa Jo Stearns, MD (Valley Cancer Pain Treatment Ctr., Division of Valley Anesthesiology Cons., Scottsdale, AZ)
-- Mark Wallace, MD (University of California San Diego, Center for Pain Medicine, San Diego, CA)
-- William D. Witt, MD (Interventional Pain Associates, Lexington, KY)
-- Nagy Mekhail, MD, PhD (Cleveland Clinic, Cleveland, OH)
-- Eric Buchser, MD (Center for Neuromodulation EHC, Morges, Switzerland)
-- Michael Cousins, MD (Royal North Shore Hospital, Sydney, Australia)
-- Leong Liem, MD
-- Anne Ver Donck, MD
The Polyanalgesic Consensus Panel was sponsored by Elan Pharmaceuticals, Inc.
PRIALT, developed by scientists at Elan, is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. PRIALT is administered through programmable microinfusion pumps that can be implanted or external and which release the drug into the fluid surrounding the spinal cord. Approved for use in 2004, PRIALT was the first intrathecal analgesic approved in the U.S. in more than two decades.
PRIALT is indicated for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are tolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine. PRIALT is in a class of non-opioid analgesics known as N-type calcium channel blockers.
WARNING: 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.
Dizziness, nausea, confusional state, and nystagmus were the most frequently reported adverse events (greater than or equal to 25%) in clinical trials (N=1,254).
PRIALT® (ziconotide intrathecal infusion) is for use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System and the CADD-Micro® ambulatory infusion pump.
Distributed by Elan Pharmaceuticals, Inc. (EPI). PRIALT® is a registered trademark of EPI. SyncroMed® is a registered trademark of Medtronic, Inc. CADD-Micro® is a registered trademark of the Smiths Medical family of companies. http://www.elan.com.
For full prescribing information for PRIALT, including boxed warning, go to http://www.PRIALT.com and additional information is available through a toll-free number: 1-888-PRIALT-1, Monday-Friday 8 AM to 7 PM Eastern Time.
Source: Elan Corp
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