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September is National Pain Awareness Month
Date:9/28/2007

SEVERE CHRONIC PAIN - ONE OF COUNTRY'S GREAT HIDDEN HEALTH CRISES - 70

MILLION AMERICANS SUFFER WITHOUT RELIEF Treatment Developed from Sea Snail Offers Relief for Severe Chronic Pain

Sufferers

NEW YORK, Sept. 28 /PRNewswire/ -- The under-treatment of pain is one of the most important public health issues facing the United States today, impacting the lives of an estimated one in three Americans, according to the National Pain Foundation. Unfortunately, many patients who suffer from severe chronic pain do not experience long-term relief from available treatments and key aspects of their daily lives -- including normal physical activity, employment, relationships and a multitude of other capacities -- are often severely compromised.(1)

However, hope exists for those who are suffering in the form of a sea snail. Researchers at Elan Pharmaceuticals, Inc., a wholly-owned subsidiary of Elan Corporation, plc, have harnessed the venom of the Conus magus sea snail into a non-narcotic alternative to traditional pain medications. PRIALT(R) (ziconotide intrathecal infusion), a synthetic form of a naturally occurring peptide, circumvents concerns over addiction and safety linked to opioid use.

"Chronic pain disrupts an individual's life and can add tremendous physical, emotional and economic burden," said Mary Pat Aardrup, executive director, National Pain Foundation. "Chronic pain is one of the great hidden crises of our time, made all the more urgent by the fact that treatment is often limited mainly to opioid medications that may be inadequate or inappropriate for many patients. PRIALT is an important chapter in the management of severe chronic pain that warrants intrathecal therapy."

Physicians and patients nationwide are discovering the pain-relieving capabilities of PRIALT. Dawn Campbell endured 32 surgeries to relieve severe pain in her bladder, back and legs, including removal of her uterus, ovaries and bladder.

"The pain was constant for 23 years and nothing I was using was helping to stop it," said Campbell.

After finally being treated with PRIALT, on the advice of her physician, Dr. Gladstone McDowell at Grant Medical Center at OhioHealth in Columbus, Ohio, Campbell is now living with less pain than before. Though it took time to find the correct dosage to experience relief, both Dawn and her doctor say it was worth it.

"Now I can do so much more, I have my life back," said Campbell.

Approved in 2004 for the management of severe chronic pain, PRIALT is administered through a programmable microinfusion pump that can be implanted or used externally. The pump then releases the drug on a timely basis into the fluid surrounding the spinal cord. Animal research suggests that the mechanism of action for PRIALT works by targeting and blocking N-type calcium channels on nerves in the spinal cord that ordinarily transmit pain signals.

Dr. McDowell explains, "It's a very innovative form of therapy that's very exciting. PRIALT is believed to block the pain by binding to the nerves that transmit pain. It saves you from being exposed to narcotics and you don't develop an addiction or tolerance to it."

Additionally, there are no withdrawal symptoms and patients can abruptly discontinue PRIALT, making it different than all other intrathecal pain medications available to patients.

According to the National Pain Foundation, chronic pain is a leading cause of distress and the primary cause of disability in the US and significantly affects the lives of an estimated 70 million Americans each day. The issue of chronic pain also impacts employers, insurance agencies, healthcare institutions and the U.S. economy, costing an estimated $100 billion annually.

Tragically, chronic pain is undertreated in the healthcare system at all levels, from physician offices, emergency rooms, hospitals and long-term care facilities for a variety of reasons. Pain may be under-diagnosed and under-treated because it is often considered a symptom of another illness or coined as a "get over it" ailment or as part of an injury or weakness, according to Arthur S. Meyerson of Pain Magazine. Additionally, as cited in recent news coverage, fear of legal or disciplinary actions may prevent physicians from using all available treatments, as providers and patients may be concerned about tolerance and addiction problems related to opioid treatments.

About PRIALT

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(R) (ziconotide intrathecal infusion) is for use only in the Medtronic SynchroMed(R) EL, SynchroMed(R) II Infusion System and the CADD-Micro(R) ambulatory infusion pump.

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

(1) Testimony of Rollin M. Gallagher, MD, MPH

Congressional Briefing: The Epidemic of Pain in America

June 13, 2006

http://www.painfoundation.org/Action/Briefing061306/GallagherTestimony.pdf


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