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Invisibleadrug

Registered: 02/04/03
Posts: 15,800
FDA Approves New Drug for Severe Pain
    #3574542 - 01/03/05 11:11 AM (11 years, 11 months ago)

http://story.news.yahoo.com/news?tmpl=st...mp;sid=95832451


WASHINGTON - Patients who suffer severe chronic pain and are no longer helped by morphine will soon have a new option.


The Food and Drug Administration (news - web sites) on Tuesday approved the first in a new class of drugs that blocks the nerve channels responsible for transmitting pain signals. It will be marketed as Prialt and should be available by the end of January.


"When you've taken all the kinds of pain medication that there is and you still have pain, that is a very frightening situation," said Dr. Lars Ekman, president of research and development for the drug's Ireland-based manufacturer, Elan. "When you have that kind of pain, there is nowhere to go."


The drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.


Morphine is standard treatment for severe pain from cancer, AIDS (news - web sites), amputations and other significant illnesses, but its effects eventually wear off and the dosage must be increased. At some point, many patients switch from taking medication by mouth or by injection to a microinfusion pump implanted under the skin that delivers drugs directly into the fluid surrounding the spinal cord.


Ekman said 35,000 to 50,000 Americans have these pumps now. The FDA (news - web sites) approved Prialt for patients who are already using these pumps but not getting effective relief from them or who cannot tolerate the available treatments.


This is the first new drug in 20 years to treat pain using such a pump.


Prialt has been studied in patients with cancer, AIDS and other chronic pain, such as back pain. More than 1,200 patients took part in three clinical trials.


There are side effects, and the FDA was including a "black box" warning ? the government's strongest warning short of a ban. Side effects may include dizziness, drowsiness and altered mental status, with patients confused at times.


Despite the side effects, the drug was approved because there are no other options for these patients and the benefits outweighed the risks, said Dr. Robert Meyer, director of the FDA's Office of Drug Evaluation II.


"Because this is such an important patient population where they have such pain and they have so few options, we felt this drug does offer some real gains," he said.


Patients with a history of psychoses should not receive it, and all others should be monitored for signs of cognitive impairment, he said.


The idea for the drug came from a snail called the Conus magus that lives in the South Pacific, which paralyzes its victims with venom after capturing them, the company said. Researchers set out to learn how to develop a drug based on this venom and eventually copied the amino acid sequence.


Elan would not say how much it plans to charge for the drug.


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Invisibleblink
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Re: FDA Approves New Drug for Severe Pain [Re: adrug]
    #3574604 - 01/03/05 11:59 AM (11 years, 11 months ago)

I'm a bit confused as to what this part means:
Quote:

The idea for the drug came from a snail called the Conus magus that lives in the South Pacific, which paralyzes its victims with venom after capturing them, the company said. Researchers set out to learn how to develop a drug based on this venom and eventually copied the amino acid sequence.




To me, paralysis and pain blocking seem to be seperate things?

Also, the drug is administered using a pump into the spinal cord right?


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Invisibleadrug

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Re: FDA Approves New Drug for Severe Pain [Re: blink]
    #3574624 - 01/03/05 12:09 PM (11 years, 11 months ago)

I have no idea about your first question, I'm just reporting the story as I read it...

And they didn't actually say how this particular drug is administered, just how morphine is typically administered.


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Re: FDA Approves New Drug for Severe Pain [Re: adrug]
    #3574641 - 01/03/05 12:17 PM (11 years, 11 months ago)

I'm tired and doped up on cold meds

they were open questions, hopefully somebody who knows will enlighten me
thanks :sun:


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Re: FDA Approves New Drug for Severe Pain [Re: blink]
    #3575745 - 01/03/05 06:58 PM (11 years, 11 months ago)

Well, the article says it blocks the nerves from sending pain signals. I imagine it does this by paralyzing them, but that isnt new technology.

And yes, the new drug would use the pump. But the pump is a tricky instillation, so they wont let people who dont have one already use this drug right now. Only people who currently use opiate-based drugs with such a pump are eligible for the trial.


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After one comes, through contact with it's administrators, no longer to cherish greatly the law as a remedy in abuses, then the bottle becomes a sovereign means of direct action.  If you cannot throw it at least you can always drink out of it.  - Ernest Hemingway

If it is life that you feel you are missing I can tell you where to find it.  In the law courts, in business, in government.  There is nothing occurring in the streets. Nothing but a dumbshow composed of the helpless and the impotent.    -Cormac MacCarthy

He who learns must suffer. And even in our sleep pain that cannot forget falls drop by drop upon the heart, and in our own despair, against our will, comes wisdom to us by the awful grace of God.  - Aeschylus


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