possible new pain medication

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Approvable Letter Issued for Ziconotide, a Novel Painkiller

by Rosemarie , BA, MA

Ziconotide Click on the active ingredient name to access more information.

Brand Name: NA

Active Ingredient: ziconotide

Indication: Treatment of chronic intractable pain

Company Name: Elan Corporation, plc

Availability: Approvable letter issued by FDA on June 28, 2000

Introduction

A novel painkiller isolated from the venom of an oceanic snail may soon be

approved for marketing to help the hundreds of thousands of people with

chronic pain that does not respond to conventional treatments. Called

ziconotide (SNX-111), the drug is manufactured by Elan Corporation, plc,

which received an approvable letter from the FDA on June 28, 2000.

Ziconotide is a manmade version of a substance isolated from the venom of

cone snails -- carnivorous oceanic snails that sting their prey with a

cocktail of nerve-damaging chemicals injected through a harpoon-like tube.

Ziconotide is 100 to 1,000 times more potent than morphine; indeed, the

cone snail venom (conotoxin) is potent enough to completely paralyze a fish

within a matter of seconds. Scientists have harnessed this creation of

nature to produce a new highly targeted painkiller that blocks critical

openings in nerve cells, interrupting pain signals on their journey through

the spinal cord to the brain. Ziconotide is administered through a small

tube directly into the spinal cord.

How Does It Work?

Pain signals depend on the transport of calcium within cells. Ziconotide

blocks the pain-associated channels through which calcium ions travel

without interfering with channels that convey normal sensations. As a

result, pain is relieved without causing numbness.

Clinical Study Results

Elan reported that the basis of the FDA approvable letter were positive

results from unpublished phase III clinical trial data on the use of

ziconotide in more than 700 patients with untreatable pain. The patients

studied had either failed therapy with narcotics or could no longer

tolerate therapy because of side effects. Significant pain relief was

achieved in 57% of these patients. (ref. 2)

Brose and colleagues (ref. 3) described the use of ziconotide in a

43-year-old man who had suffered from chronic pain for 23 years after

damage to the brachial plexus -- a network of nerves in the neck and

shoulder. The patient reported complete relief of his pain.

Adverse Events

Adverse side effects reported by patients receiving ziconotide included

dizziness, blurred vision, and jittery eye movement -- effects that could

be resolved by reducing the dosage. Some patients experienced a slight

reduction in blood pressure. Patients did not show signs of tolerance or

addiction, even after many months of treatment.

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References

" Elan announces receipt of FDA approvable letter for ziconotide. " Press

release, Elan Corporation, plc, June 28, 2000.

" Elan submits NDA for ziconotide. " Press release, Elan Corporation, plc,

December 31, 1999.

Brose, WG, et al. " Use of intrathecal SNX-111, a novel, N-type,

voltage-sensitive, calcium channel blocker, in the management of

intractable brachial plexus avulsion pain. " Clinical J Pain 1997;13:256-259

Gibbs, WW. " A New Way to Spell Relief: V-e-n-o-m. " Scientific American,

February 1996, pages 28-29.

Arnst, C, et al. " Conquering Pain. " Business Week, March 1, 1999 issue..